FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ACTIVE
MDR report key: 1770953
·
Received November 13, 2007
Report
- Report Number
- 1823260-2007-09891
- Event Type
- Malfunction
- Date Received
- November 13, 2007
- Date of Event
- October 31, 2007
- Report Date
- November 13, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K021827
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED BLOOD GLUCOSE RESULT OF LO (LESS THAN 10 MG/DL) IMMEDIATELY AFTER THE UNDOSED TEST STRIP WAS INSERTED IN THE ACTIVE S METER. NO ACTIONS WERE REPORTED TAKEN OR TREATMENTS RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ACTIVE | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | COZAAR - 2-3 YEARS - 100MG ONCE DAILY| VITAMIN B12 - 5 YEARS - DOSAGE UNK ONCE DAILY| VITAMIN D - 5 YEARS - DOSAGE UNK| HUMULIN N - 15 YEARS - 57 UNITS DAILY| LIPITOR - 5 YEARS - 20MG ONCE DAILY| METOPROLOL - 5 YEARS - 50MG 1/2 TAB ONCE DAILY| BABY ASPIRIN - 2 MONTHS - 81MG ONCE DAILY| VITAMIN B6 - 5 YEARS - 1000 IU ONCE DAILY| HUMULIN R - 15 YEARS - 10 UNITS DAILY| GARLIC SUPPLEMENT - 5 YEARS - 1000MG ONCE DAILY| AMLODIPINE - 5 YEARS - 10MG ONCE DAILY |