FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1032692
·
Received April 22, 2008
Report
- Report Number
- 1823260-2008-03426
- Event Type
- Malfunction
- Date Received
- April 22, 2008
- Date of Event
- April 7, 2008
- Report Date
- April 22, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
CUSTOMER'S DAUGHTER REPORTS BACK TO BACK TESTING TO A PROFESSIONAL METER WHILE USING THE ADVANTAGE SYSTEM WITH RESULTS 338 MG/DL ON CUSTOMER'S METER AND 138 MG/DL ON PROFESSIONAL METER. NO QUALITY CONTROLS WERE RUN. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING DEVICE-LFR | LFR | ROCHE DIAGNOSTICS | 549915 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | NOVOLIN| LISINOPROL HCTZ| AMITRIPTYLINE| HERBS SHE BRINGS FROM MEXICO - UNK| NOVOLIN 70/30 72 UNITS 6PM| ASA| SIMVASTATIN| LEVOTHYROXINE| METFORMIN |