FDA Adverse Event
Injury
Summary report: N
ACCU-CHEK III
MDR report key: 38919
·
Received September 16, 1996
Report
- Report Number
- 1823260-1996-00095
- Event Type
- Injury
- Date Received
- September 16, 1996
- Date of Event
- September 4, 1996
- Report Date
- September 4, 1996
- Manufacturer
- BOEHRINGER MANNHEIM CORP
- Product Code
- CFR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
STANDARD DISCLAIMER ON FILE.
Description of Event or Problem · 1
A DIABETIC REPORTS A HYPOGLYCEMIC EVENT INVOLVING A FALL TO THE FLOOR AND UNCONSCIOUSNESS FOR AN UNKNOWN PERIOD. DUE TO THE EVENT, THE DIABETIC SUFFERED A "BUMP" TO THE HEAD. NO TREATMENT WAS GIVEN. THE DIABETIC REGAINED CONSCIOUSNESS WITHOUT ASSISTANCE. THE DEVICE HAD REPORTED A FASTING BLOOD GLUCOSE VALUE OF 285 MG/DL IN THE EARLY MORNING. THE DIABETIC FELT DIZZY AND "PASSED OUT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK III | BLOOD GLUCOSE MONITORING TEST STRIPS | CFR | BOEHRINGER MANNHEIM CORP | 766 | 252494 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Life Threatening |