FDA Adverse Event
Malfunction
Summary report: N
CONTOUR TEST STRIPS (10)
MDR report key: 1163688
·
Received September 9, 2008
Report
- Report Number
- 1826988-2008-01032
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 27, 2008
- Report Date
- August 27, 2008
- Manufacturer
- BAYER HEALTHCARE LLC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER CALLED FOR HELP WITH HER NEW CONTOUR METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED A RESULT OF 61 MG/DL. THE NORMAL CONTROL RANGE WAS 102-141 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR TEST STRIPS (10) | BLOOD GLUCOSE TEST STRIPS | NBW | BAYER HEALTHCARE LLC. | 9507B | 7LC3D54 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |