FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK INFORM METER
MDR report key: 1761177
·
Received July 13, 2007
Report
- Report Number
- 1823260-2007-06126
- Event Type
- Malfunction
- Date Received
- July 13, 2007
- Date of Event
- July 3, 2007
- Report Date
- July 13, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- K012210
- Removal / Correction Number
- Z-1060-04
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER STATES THE 3RD AND 4TH CONNECTOR PINS ON THE INFORM SYSTEM ARE BLACKENED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK INFORM METER | BLOOD GLUCOSE MONITORING DEVICE - NBW | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |