FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT PLUS
MDR report key: 1002652
·
Received February 8, 2008
Report
- Report Number
- 1823260-2008-01371
- Event Type
- Malfunction
- Date Received
- February 8, 2008
- Date of Event
- January 29, 2008
- Report Date
- February 8, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K031755
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED SEGMENTS WERE MISSING FROM THE DISPLAY IN THE NUMBER RESULT FIELD OF THE COMPACT PLUS SYSTEM. REPORTER DISCOVERED THE ALLEGED DISPLAY ISSUE WHEN SHE CALLED THE MANUFACTURER. NO ACTIONS OR TREATMENTS WERE REPORTED. 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 COMPACT PLUS | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | AVANDIA - 5 YEARS / 4 MG TWICE DAILY| LANTUS - 3 YEARS / 80 UNITS ONCE DAILY| METFORMIN - 8 YEARS / 1000 MG TWICE DAILY| GLIPIZIDE - 8 YEARS / 10MG TWICE DAILY |