FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMPACT METER
MDR report key: 3112098
·
Received June 9, 2006
Report
- Report Number
- 1823260-2006-07866
- Event Type
- Malfunction
- Date Received
- June 9, 2006
- Date of Event
- March 1, 2006
- Report Date
- March 2, 2006
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- Removal / Correction Number
- Z-0976-05
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED THE BLOOD GLUCOSE DEVICE GENERATED A RESULT PRIOR TO THE TEST STRIP BEING DOSED WITH BLOOD OR CONTROL SOLUTION. REPORTER STATED BEING UNSURE OF THE NUMERIC VALUE OF THE READING. NO ACTIONS WERE REPORTEDLY TAKEN OR TREATMENT RECEIVED AS A RESULT. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMPACT METER | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | 70/30 HUMALIN| COZAAR |