FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ADVANTAGE TEST STRIPS
MDR report key: 1022682
·
Received April 1, 2008
Report
- Report Number
- 1823260-2008-02907
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- March 21, 2008
- Report Date
- April 1, 2008
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K982089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
RETENTION SAMPLES HAVE EXPIRED, THEREFORE, ONLY HISTORICAL DATA IS AVAILABLE.
Description of Event or Problem · 1
CUSTOMER REPORTS THE USE BY DATE ON THE ADVANTAGE TEST STRIP VIAL AS 03/28/2008. MFR'S DATABASE AND BATCH RECORD CONFIRMED THE ACTUAL USE BY DATE TO BE 04/30/2005. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ADVANTAGE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS - LFR | LFR | ROCHE DIAGNOSTICS | 522719 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | GLUCOVANCE 500MG| QUINAPRIL 10MG/DAY - 10 YEARS |