FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT PLUS (GT)
MDR report key: 1241656
·
Received November 19, 2008
Report
- Report Number
- 1823260-2008-08564
- Event Type
- Malfunction
- Date Received
- November 19, 2008
- Date of Event
- November 6, 2008
- Report Date
- November 19, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K081389
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED ICONS WERE MISSING FROM THE DISPLAY OF THE COMPACT PLUS SYSTEM. REPORTER IS FROM THE MFR'S EVALUATIONS DEPARTMENT AND DISCOVERED THE ALLEGED ISSUE AFTER THE DEVICE WAS RETURNED. NO ACTIONS OR TREATMENTS WERE REPORTED. NO ADVERSE EVENT REPORTED. THE SUSPECT DEVICE WAS RETURNED AND REPLACEMENT PRODUCT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMPACT PLUS (GT) | BLOOD GLUCOSE MONITORING DEVICE- NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | NOVOLOG- 7 MONTHS- SLIDING SCALE| LANTUS- 7 MONTHS- 52 UNITS DAILY| METFORMIN- 7 MONTHS- 1000MG DAILY |