FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 841219
·
Received February 28, 2007
Report
- Report Number
- 1823260-2007-01713
- Event Type
- Malfunction
- Date Received
- February 28, 2007
- Date of Event
- February 9, 2007
- Report Date
- February 28, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED RESULTS OF 396MG/DL AND 103MG/DL ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO INFO PROVIDED ON LOCATION OF COMPARISON. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549421, EXP 01/31/2008, 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 | * | 549421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | COZAAR - 3 YRS 50MG ONCE DAILY| NEURONTIN - 3 YRS 400MG AT BED| NEURONTIN 3 YRS 100MG ONE PILL TWICE DA| LASIX 2-3 MONTHS 40MG ONCE DAILY| DICLOFENAC - 1 YR 75 TWICE DAILY| PRAVACHOL - 3 YRS 20MG ONCE DAILY| LEVOXYL 10+ YRS 88MCG ONCE DAILY |