Device Malfunction |
Other Serious |
|
|
Female |
|
12/1/2009 |
Consumer |
United States |
|
Retinopathy |
Other Serious |
|
57 |
Male |
|
12/28/2009 |
Consumer |
United States |
|
Retinopathy |
Other Serious |
|
57 |
Male |
|
1/5/2010 |
Consumer |
United States |
|
Yellow Skin |
Hospitalization |
12/1/2009 |
|
Female |
|
1/5/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Fluctuation |
Other Serious |
|
65 |
Female |
|
1/11/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
|
|
|
|
1/28/2010 |
Physician |
South Africa |
|
Device Malfunction |
Other Serious |
|
64 |
Male |
|
2/1/2010 |
Physician |
Hungary |
Primary |
|
Secondary |
|
Concomitant |
|
|
Product Quality Issue |
Other Serious |
|
|
|
|
2/3/2010 |
Pharmacist |
Germany |
|
Retinopathy |
Other Serious |
|
57 |
Male |
|
2/4/2010 |
Consumer |
United States |
|
Product Quality Issue |
Other Serious |
|
|
Male |
|
2/5/2010 |
Pharmacist |
Germany |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
2/8/2010 |
Consumer |
United States |
|
Retinopathy |
Other Serious |
|
57 |
Male |
|
2/9/2010 |
Consumer |
United States |
|
Road Traffic Accident |
Other Serious |
|
|
Female |
|
2/16/2010 |
Consumer |
United States |
|
Vision Blurred |
Other Serious |
|
|
Female |
|
2/16/2010 |
Other Health Professional |
United States |
|
Device Malfunction |
Other Serious |
|
|
Female |
|
2/17/2010 |
Consumer |
Canada |
|
Wrong Drug Administered |
Other Serious |
2/8/2010 |
53 |
Female |
|
2/18/2010 |
Consumer |
United States |
|
Rash |
Hospitalization |
2/1/2010 |
87 |
Male |
|
2/22/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Product Quality Issue |
Other Serious |
|
|
Male |
|
3/2/2010 |
Pharmacist |
Germany |
|
Product Quality Issue |
Death |
12/31/2009 |
|
Male |
|
3/5/2010 |
Consumer |
United States |
|
Wrong Drug Administered |
Other Serious |
2/8/2010 |
53 |
Female |
|
3/8/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
3/9/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
|
|
Female |
|
3/10/2010 |
Consumer |
United States |
|
Product Quality Issue |
Death |
12/31/2009 |
|
Male |
|
3/10/2010 |
Consumer |
United States |
|
Hysterectomy |
Other Serious |
11/1/2009 |
88 |
Female |
|
3/18/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
|
64 |
Male |
|
3/18/2010 |
Physician |
Hungary |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
|
|
|
|
3/19/2010 |
Pharmacist |
United States |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
3/31/2010 |
Consumer |
United States |
|
Blood Glucose Increased |
|
1/1/2009 |
75 |
Female |
|
4/2/2010 |
Consumer |
|
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
2/8/2010 |
|
|
|
4/6/2010 |
Physician |
Japan |
|
Device Malfunction |
Other Serious |
|
|
Female |
|
4/7/2010 |
Consumer |
United States |
|
Wrong Drug Administered |
Other Serious |
3/31/2010 |
72 |
Female |
|
4/15/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
|
|
Female |
|
4/16/2010 |
Consumer |
United States |
|
Wrong Drug Administered |
Other Serious |
3/31/2010 |
72 |
Female |
|
4/19/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
|
|
Male |
|
4/20/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
|
|
Female |
|
4/20/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
|
|
|
|
4/20/2010 |
Pharmacist |
United States |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
4/20/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
2/8/2010 |
|
|
|
4/26/2010 |
Physician |
Japan |
|
Device Malfunction |
Other Serious |
|
|
|
|
4/28/2010 |
Physician |
South Africa |
|
Yellow Skin |
Hospitalization |
12/1/2009 |
68 |
Female |
185 lb |
5/6/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Meniscus Lesion |
Other Serious |
1/1/2010 |
72 |
Female |
|
5/10/2010 |
Consumer |
United States |
|
Fall |
Hospitalization |
4/1/2010 |
68 |
Male |
|
5/10/2010 |
Consumer |
United States |
|
Cataract |
Other Serious |
1/1/2009 |
82 |
Male |
|
5/21/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
6/3/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
5/26/2010 |
|
|
|
6/3/2010 |
Physician |
Japan |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
6/7/2010 |
Consumer |
United States |
|
Thrombosis |
Hospitalization |
5/1/2010 |
85 |
Male |
|
6/14/2010 |
Consumer |
United States |
|
Weight Decreased |
Other Serious |
|
35 |
Female |
133 lb |
6/14/2010 |
Consumer |
Turkey |
Primary |
|
Secondary |
|
Concomitant |
|
|
Upper Limb Fracture |
Other Serious |
1/1/2008 |
64 |
Male |
|
6/14/2010 |
Consumer |
United States |
|
Pain In Extremity |
Hospitalization |
|
|
Female |
|
6/22/2010 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
4/9/2010 |
|
|
|
6/22/2010 |
Physician |
Japan |
|
Cataract |
Other Serious |
1/1/2009 |
82 |
Male |
141 lb |
6/23/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hyperglycaemia |
Hospitalization |
|
43 |
Female |
|
7/1/2010 |
Other Health Professional |
United States |
|
Device Malfunction |
Other Serious |
|
|
Male |
|
7/19/2010 |
Consumer |
United States |
|
Hyperglycaemia |
Other Serious |
|
43 |
Female |
|
7/20/2010 |
Other Health Professional |
United States |
|
Visual Acuity Reduced |
Other Serious |
1/1/2010 |
61 |
Male |
|
7/21/2010 |
Consumer |
United States |
|
Thrombosis |
Hospitalization |
5/1/2010 |
85 |
Male |
216 lb |
8/2/2010 |
Consumer |
United States |
|
Road Traffic Accident |
Other Serious |
2/1/2010 |
65 |
Male |
|
8/2/2010 |
Consumer |
United States |
|
Hepatic Function Abnormal |
Other Serious |
1/14/2010 |
|
Female |
|
8/6/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
5/26/2010 |
|
|
|
8/9/2010 |
Physician |
Japan |
|
Renal Failure Chronic |
Other Serious |
|
59 |
Female |
|
8/10/2010 |
Consumer |
United States |
|
Sepsis |
Hospitalization |
12/21/2008 |
62 |
Female |
|
8/12/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hypoglycaemic Unconsciousness |
Other Serious |
1/1/2010 |
46 |
Female |
|
8/18/2010 |
Consumer |
United States |
|
Blood Potassium Increased |
Hospitalization |
8/14/2010 |
71 |
Female |
|
9/2/2010 |
Consumer |
United States |
|
Product Quality Issue |
Hospitalization |
|
53 |
Female |
|
9/3/2010 |
Consumer |
United States |
|
Weight Increased |
Other Serious |
1/1/2009 |
69 |
Female |
159 lb |
9/7/2010 |
Consumer |
Brazil |
Primary |
|
Secondary |
|
Concomitant |
|
|
Road Traffic Accident |
Other Serious |
2/1/2010 |
65 |
Male |
|
9/9/2010 |
Consumer |
United States |
|
Injection Site Haematoma |
Other Serious |
8/29/2010 |
66 |
Male |
|
9/10/2010 |
Consumer |
United States |
|
Vision Blurred |
Other Serious |
5/1/2010 |
63 |
Male |
176 lb |
9/13/2010 |
Consumer |
United States |
|
Road Traffic Accident |
Other Serious |
2/1/2010 |
65 |
Male |
|
9/29/2010 |
Consumer |
United States |
|
Product Quality Issue |
Hospitalization |
|
53 |
Female |
|
10/12/2010 |
Consumer |
United States |
|
Product Quality Issue |
Hospitalization |
10/24/2010 |
62 |
Male |
|
11/2/2010 |
Consumer |
United States |
|
Wrong Drug Administered |
Other Serious |
1/1/2007 |
68 |
Female |
161 lb |
11/3/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
|
68 |
Female |
|
11/5/2010 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Staphylococcal Infection |
Other Serious |
10/1/2010 |
57 |
Female |
|
11/19/2010 |
Consumer |
United States |
|
Lung Neoplasm Malignant |
Other Serious |
1/1/2010 |
74 |
Female |
|
11/22/2010 |
Consumer |
United States |
|
Pancreatic Carcinoma |
Death |
11/12/2010 |
65 |
Male |
|
12/3/2010 |
Physician |
Japan |
Primary |
|
Secondary |
|
Concomitant |
|
|
Jaundice |
Other Serious |
11/26/2010 |
22 |
Male |
176 lb |
12/13/2010 |
Physician |
Turkey |
|
Wrong Drug Administered |
Other Serious |
2/8/2010 |
53 |
Female |
|
12/20/2010 |
Consumer |
United States |
|
Product Quality Issue |
Other Serious |
12/14/2010 |
61 |
Female |
|
12/21/2010 |
Consumer |
United States |
|
Product Quality Issue |
Hospitalization |
10/24/2010 |
62 |
Male |
|
12/27/2010 |
Consumer |
United States |
|
Hyperglycaemia |
Hospitalization |
10/24/2010 |
62 |
Male |
|
1/20/2011 |
Consumer |
United States |
|
Condition Aggravated |
Other Serious |
|
|
Female |
181 lb |
1/28/2011 |
Other Health Professional |
Brazil |
Primary |
|
Secondary |
|
Concomitant |
|
|
Visual Impairment |
Other Serious |
|
65 |
Male |
|
1/31/2011 |
Consumer |
United States |
|
Renal Failure Chronic |
Other Serious |
10/1/2010 |
57 |
Female |
291 lb |
2/4/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Headache |
Other Serious |
12/14/2010 |
61 |
Female |
|
2/4/2011 |
Consumer |
United States |
|
Vision Blurred |
Other Serious |
1/1/2005 |
69 |
Male |
|
2/8/2011 |
Consumer |
United States |
|
Speech Disorder |
Other Serious |
9/17/2010 |
59 |
Female |
|
2/23/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
Other Serious |
|
59 |
Female |
|
2/24/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Injection Site Haemorrhage |
Other Serious |
|
59 |
Female |
|
3/22/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Diabetic Coma |
Other Serious |
1/1/2008 |
58 |
Female |
|
3/25/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Malaise |
Other Serious |
12/14/2010 |
61 |
Female |
|
3/31/2011 |
Consumer |
United States |
|
Product Quality Issue |
Other Serious |
12/14/2010 |
61 |
Female |
|
4/5/2011 |
Consumer |
United States |
|
Hyperglycaemia |
Hospitalization |
1/1/2008 |
|
Female |
141 lb |
4/6/2011 |
Pharmacist |
Brazil |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Increased |
Other Serious |
3/29/2011 |
78 |
Female |
|
4/7/2011 |
Consumer |
United States |
|
Macular Degeneration |
Other Serious |
3/29/2011 |
78 |
Female |
|
4/15/2011 |
Consumer |
United States |
|
Hypoglycaemia |
Other Serious |
|
|
Male |
|
4/15/2011 |
Consumer |
Japan |
|
Knee Arthroplasty |
Other Serious |
5/2/2010 |
66 |
Female |
|
4/26/2011 |
Consumer |
United States |
|
Glycosylated Haemoglobin Increased |
Other Serious |
1/1/2008 |
58 |
Female |
|
4/26/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Clostridial Infection |
Other Serious |
|
75 |
Male |
|
4/29/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
|
12/1/2009 |
62 |
Male |
|
5/3/2011 |
Consumer |
United States |
|
Vision Blurred |
|
|
|
Female |
|
5/4/2011 |
Consumer |
United States |
|
Dyspnoea |
|
1/1/2010 |
65 |
Female |
|
5/4/2011 |
Consumer |
United States |
|
Hypoglycaemia |
Other Serious |
6/9/2010 |
|
Male |
|
5/4/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Visual Acuity Reduced |
|
|
77 |
Female |
|
5/4/2011 |
Consumer |
United States |
|
Fatigue |
|
6/1/2010 |
71 |
Female |
|
5/4/2011 |
Consumer |
United States |
|
Dizziness |
Other Serious |
|
72 |
Female |
|
5/4/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hypoglycaemia |
Other Serious |
12/22/2010 |
35 |
Male |
|
5/4/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Increased |
Other Serious |
2/1/2011 |
77 |
Male |
168 lb |
5/4/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Accidental Overdose |
Other Serious |
1/1/2011 |
82 |
Male |
|
5/4/2011 |
Consumer |
United States |
|
Drug Ineffective |
Other Serious |
1/1/2011 |
52 |
Female |
|
5/4/2011 |
Consumer |
United States |
|
Nausea |
|
7/1/2010 |
|
Female |
|
5/4/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Eye Injury |
|
4/1/2010 |
63 |
Male |
|
5/4/2011 |
Consumer |
United States |
|
Wrong Technique In Drug Usage Process |
|
|
65 |
Female |
|
5/9/2011 |
Consumer |
United States |
|
Vision Blurred |
|
|
53 |
Female |
180 lb |
5/9/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Full Blood Count Abnormal |
|
|
61 |
Female |
|
5/9/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Feeling Jittery |
|
11/2/2010 |
83 |
Female |
|
5/9/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Injection Site Injury |
|
11/1/2010 |
82 |
Female |
|
5/9/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Insomnia |
|
1/1/2011 |
68 |
Female |
|
5/9/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Glycosylated Haemoglobin Increased |
|
|
79 |
Female |
|
5/9/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
|
1/1/2010 |
60 |
Male |
|
5/9/2011 |
Consumer |
United States |
|
Injury Associated With Device |
|
|
66 |
Female |
|
5/9/2011 |
Consumer |
United States |
|
Burning Sensation |
|
4/12/2011 |
|
Female |
|
5/9/2011 |
Consumer |
United States |
|
Device Malfunction |
Other Serious |
1/1/2009 |
54 |
Female |
|
5/23/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hyperhidrosis |
Hospitalization |
|
62 |
Male |
|
6/7/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Increased |
Other Serious |
6/17/2011 |
76 |
Female |
|
6/24/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hypoglycaemia |
Hospitalization |
6/11/2011 |
64 |
Female |
167 lb |
6/24/2011 |
Physician |
United Kingdom |
Primary |
|
Secondary |
|
Concomitant |
|
|
Device Malfunction |
Other Serious |
|
|
Male |
|
6/29/2011 |
Consumer |
Japan |
|
Hypoglycaemia |
Hospitalization |
6/1/2011 |
84 |
Female |
|
7/1/2011 |
Consumer |
Germany |
|
Product Quality Issue |
Other Serious |
6/30/2011 |
67 |
Male |
|
7/11/2011 |
Consumer |
United States |
|
Clostridial Infection |
Other Serious |
|
75 |
Male |
|
7/19/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
Other Serious |
|
36 |
Female |
300 lb |
7/21/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Hypoglycaemia |
Other Serious |
1/1/2009 |
54 |
Female |
202 lb |
7/22/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Increased |
Other Serious |
|
|
Male |
|
8/3/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
Other Serious |
|
36 |
Female |
300 lb |
8/16/2011 |
Consumer |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Wrong Drug Administered |
Hospitalization |
6/11/2011 |
64 |
Female |
167 lb |
8/23/2011 |
Physician |
United Kingdom |
Primary |
|
Secondary |
|
Concomitant |
|
|
Diabetic Retinopathy |
Other Serious |
|
54 |
Male |
|
8/25/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
Other Serious |
|
58 |
Female |
|
8/29/2011 |
Consumer |
United States |
|
Wrong Drug Administered |
Hospitalization |
|
11 |
Female |
|
8/30/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Increased |
Other Serious |
|
54 |
Male |
|
8/31/2011 |
Consumer |
United States |
|
Cellulitis |
Other Serious |
1/1/2011 |
37 |
Male |
|
9/1/2011 |
Consumer |
United States |
|
Breast Lump Removal |
Other Serious |
|
|
Male |
|
9/5/2011 |
Consumer |
United States |
|
Convulsion |
Other Serious |
8/1/2011 |
|
Male |
|
9/5/2011 |
Consumer |
Brazil |
|
Diabetic Ketoacidosis |
Hospitalization |
|
11 |
Female |
|
9/7/2011 |
Other Health Professional |
United States |
Primary |
|
Secondary |
|
Concomitant |
|
|
Wrong Drug Administered |
Hospitalization |
8/27/2011 |
|
|
|
9/8/2011 |
Consumer |
United States |
|
Nervousness |
Other Serious |
8/29/2011 |
85 |
Female |
|
9/9/2011 |
Consumer |
Brazil |
Primary |
|
Secondary |
|
Concomitant |
|
|
Blood Glucose Increased |
Other Serious |
6/30/2011 |
67 |
Male |
|
9/12/2011 |
Consumer |
United States |
|
Wrong Drug Administered |
Hospitalization |
8/27/2011 |
|
|
|
9/26/2011 |
Consumer |
United States |
|
Cellulitis |
Other Serious |
7/9/2011 |
37 |
Male |
|
9/28/2011 |
Consumer |
United States |
|
Blood Glucose Increased |
Other Serious |
9/1/2011 |
60 |
Female |
|
10/4/2011 |
Consumer |
United States |
|