FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 731134
·
Received June 22, 2006
Report
- Report Number
- 1823260-2006-03000
- Event Type
- Malfunction
- Date Received
- June 22, 2006
- Date of Event
- May 16, 2006
- Report Date
- June 2, 2006
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
VIAL OF STRIPS PRODUCING 74MG/DL RESULTS: 548996, 04/30/2007, 2030381.
Description of Event or Problem · 1
CALLER REPORTS THAT SHE OBTAINED RESULTS OF 286 MG/DL ON ONE VIAL OF STRIPS AND CHANGED TO A NEW VIAL OF STRIPS TO RECEIVED A RESULT OF 74 MG/DL. NO ADVERSE EVENT REPORTED AND NO TREATMENT RECEIVED. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT DEIVCE 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 TEST STRIPS | NBW | ROCHE DIAGNOSTICS | NA | 548986 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | NOVALOG| ACCU-CHEK ADVANTAGE| AVANDIA| LANTUS |