FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 842287
·
Received February 27, 2007
Report
- Report Number
- 1823260-2007-01675
- 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 STRIP.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED A RESULT OF 248 MG/DL ON ADVANTAGE TEST SYSTEM 1 AND 112 MG/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. INFORMATION SUGGESTS COMPARISON WAS PERFORMED IN THE HOME. ADVANTAGE TEST SYSTEM 1: METER, STRIP LOT 548738, EXP 02/28/2007, CAT/ 2030373. ADVANTAGE TEST SYSTEM 2: METER, STRIP LOT 549561, EXP 03/31/2008, 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 | * | 2/28/2007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | METFORMIN, 10 YRS 1000MG/ 2 X DAY| ACTOS, 5 YRS. 30 MG/ 1 X DAY| GLIPIZIDE, 10 YRS. 5 MG/ 1 X DAY |