FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 841614
·
Received February 27, 2007
Report
- Report Number
- 1823260-2007-01674
- Event Type
- Malfunction
- Date Received
- February 27, 2007
- Date of Event
- February 11, 2007
- Report Date
- February 27, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUSPECT DEVICE IS COMFORT CURVE STRIPS LOT 549561.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED A RESULT OF 248MG/DL ON ADVANTAGE TEST SYSTEM 1 AND 112MG/DL ON ADVANTAGE TEST SYSTEM 2. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. INFO SUGGESTS COMPARISON WAS PERFORMED IN THE HOME. ADVANTAGE TEST SYSTEM 1: STRIP LOT 548738, EXP 2/28/07. CAT/2030373. ADVANTAGE TEST SYSTEM 2: METER 8123603399, STRIP LOT 549561 EXP 3/31/08, CAT/2030373.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | * | 549561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | GLIPIZIDE - 10 YRS. 5MG/1X DAY| METFORMIN - 10 YEARS. 1000MG/2X DAY| ACTOS - 5 YRS. 30 MG/1X DAY |