FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 854734
·
Received March 2, 2007
Report
- Report Number
- 1823260-2007-01786
- Event Type
- Malfunction
- Date Received
- March 2, 2007
- Date of Event
- January 16, 2007
- Report Date
- March 2, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED A RESULT OF 105MG/DL ON THE ADVANTAGE TEST SYSTEM AND 228MG/DL ON THE DOCTOR'S METER WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. INFORMATION SUGGESTS COMPARISON WAS PERFORMED AT THE DOCTOR'S OFFICE. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549226, EXP 10/31/07, CAT/2030381.
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 | * | 549226 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | LIPITOR - 5 YRS 10MG ONCE A DAY| AVANDIA - 5 YRS 4MG ONCE A DAY| POTASSIUM - 5 YRS 10MG ONCE A DAY| COZAAR - 5 YRS 25MG ONCE A DAY |