FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 872116
·
Received March 21, 2007
Report
- Report Number
- 1823260-2007-02281
- Event Type
- Malfunction
- Date Received
- March 21, 2007
- Date of Event
- February 24, 2007
- Report Date
- March 21, 2007
- Manufacturer
- ROCHE DIAGNOSTICS CORP.
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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 52MG/DL, 110MG/DL, AND 64MG/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. INFORMATION NOT PROVIDED ON WHERE COMPARISON OCCURRED. ADVANTAGE TEST SYSTEM: METER, STRIP LOT 549627, EXPIRATION DATE 05/31/2008, CATALOG 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 CORP. | * | 549627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | METFORMIN - 5YRS 1000MG/ 2X A DAY| LANTUS - 1YR 40CC'S| AMARYL - 5YRS 4MG/ 2X A DAY |