FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1032035
·
Received April 21, 2008
Report
- Report Number
- 1823260-2008-03394
- Event Type
- Malfunction
- Date Received
- April 21, 2008
- Date of Event
- April 5, 2008
- Report Date
- April 21, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
THE REPORTER STATES THAT SHE OBTAINED BLOOD GLUCOSE COMPARISONS WITH RESULTS 420MG/DL, 369MG/DL, 220MG/DL, 138MG/DL, 150MG/DL, 102MG/DL AND 89MG/DL ON ACCU-CHEK ADVANTAGE SYSTEM (#8122705139). THE RESULTS WERE OBTAINED WITHIN A 10 MINUTE TIMEFRAME. SHE TREATED HERSELF AND FELT BETTER AFTER TREATMENT. NO ADVERSE EVENT REPORTED. A NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STIPS - LFR | LFR | ROCHE DIAGNOSTICS | 550500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | "LEVEMIR 50-55 UNITS/DAY" 1.5 MONTHS| APIDRA SLIDING SCALE 1.5 MONTHS |