FDA Adverse Event
Malfunction
Summary report: N
CONTOUR
MDR report key: 2094013
·
Received April 20, 2011
Report
- Report Number
- 1826988-2011-00200
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 22, 2011
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CALL ENDED BEFORE THE CUSTOMER'S PERSONAL INFORMATION OR PRODUCT INFORMATION COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER WITHOUT THE METER INFORMATION.
Description of Event or Problem · 1
THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 180 MG/DL FROM HER CONTOUR METER AND READINGS BETWEEN 400-500 MG/DL USING ANOTHER METER. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER DECLINED TO TROUBLESHOOT OR PROVIDE ADDITIONAL INFORMATION BEFORE ENDING THE CALL. NO PRODUCT WILL BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR | NBW | BAYER HEALTHCARE, LLC | NOT PROVIDED | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |