FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 840680
·
Received February 27, 2007
Report
- Report Number
- 1823260-2007-01668
- Event Type
- Malfunction
- Date Received
- February 27, 2007
- Date of Event
- February 8, 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
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
SUSPECT DEVICE IS COMFORT CURVE TEST STRIPS.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED RESULTS OF 256MG/DL AND 130MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE TEST SYSTEM. NO ACTION WAS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. NO INFO PRESENTED TO SUGGEST WHERE COMPARISON WAS PERFORMED. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549405, EXP 12/31/2007, CATALOG 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 | * | 549405 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | GLIPIZIDE 2 YEARS 5MG/1 TAB/1X A DAY| LISINOPRIL 2 YEARS 5 MG (AM) 10MG(PM)| ZOCOR 4 YEARS 20MG/1 TAB/1X A DAY |