FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK INFORM METER
MDR report key: 872660
·
Received March 20, 2007
Report
- Report Number
- 1823260-2007-02257
- Event Type
- Malfunction
- Date Received
- March 20, 2007
- Date of Event
- March 1, 2007
- Report Date
- March 20, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- k012210
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SUSPECT PRODUCT IS THE INFORM METER.
Description of Event or Problem · 1
CUSTOMER USING ACCU-CHEK INFORM SYSTEM. CUSTOMER REPORTS METER PINS 1, 2, 3, 6, 7, 8 ARE BLACKENED. NO MELTING OF PLASTIC. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT. INFO SUGGESTS ISSUE DISCOVERED AT MEDICAL FACILITY. ACCU-CHEK INFORM SYSTEM: METER, TEST STRIP INFO NOT PROVIDED.
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 |