FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 854746
·
Received March 13, 2007
Report
- Report Number
- 1823260-2007-02053
- Event Type
- Malfunction
- Date Received
- March 13, 2007
- Date of Event
- February 13, 2007
- Report Date
- March 12, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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 140MG/DL ON THE ADVANTAGE TEST SYSTEM AND 80MG/DL ON THE DOCTOR'S DEVICE WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULT. NO ADVERSE EVENT REPORTED. QUALITY CONTROLS WERE USED AND REPORTEDLY FELL WITHIN ACCEPTABLE LIMITS. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549409, EXP 12/31/07, CAT/2030381. COMPARISON PERFORMED AT THE DOCTOR'S OFFICE.
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 | * | 549409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | METFORMIN - 750MG TWICE A DAY |