FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA CONTOUR
MDR report key: 1082813
·
Received July 24, 2008
Report
- Report Number
- 1826988-2008-00791
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 27, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THAT SHE PERFORMED CONTROL TESTS USING HER CONTOUR METER AND RECEIVED A RESULT OF 300 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 100-140 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT OR PROVIDE REAGENT INFORMATION BEFORE ENDING THE CALL. NO PRODUCT WILL BE RETURNED FOR EVALUATION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA CONTOUR | BLOOD GLUCOSE MONITORING TEST STRIPS- LFR | NBW | BAYER HEALTHCARE, LLC | 7151B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |