FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1012440
·
Received March 13, 2008
Report
- Report Number
- 1823260-2008-02396
- Event Type
- Malfunction
- Date Received
- March 13, 2008
- Date of Event
- March 11, 2008
- Report Date
- March 13, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTEDLY OBTAINED RESULTS OF 318 MG/DL AND 142 MG/DL ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES. NO ACTION TAKEN ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING DEVICE - LFR | LFR | ROCHE DIAGNOSTICS | 550051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | FORMOTEROL FUMARATE 24MG/DAY - 2 YEARS| SIMVASTATIN 40MG/DAY - 2 YEARS| FUROSEMIDE 1000MG/DAY - 2 YEARS| LISINOPRIL 10MG/DAY - 2 YEARS| ATENOLOL| 70/30 INSULIN| METFORMIN 1000MG/DAY - 2 YEARS| MOMETASONE 4 PUFFS/DAY - 2 YEARS |