FDA Adverse Event
Malfunction
Summary report: N
CONTOUR
MDR report key: 1850224
·
Received September 22, 2010
Report
- Report Number
- 1826988-2010-00658
- Event Type
- Malfunction
- Date Received
- September 22, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 10, 2010
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE ADVOCATE ENDED THE CALL 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 ADVOCATE STATED THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 19 MG/DL FROM HER CONTOUR METER AND A READING OF 200 MG/DL FROM 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 ADVOCATE ENDED THE CALL BEFORE ANY ADDITIONAL INFORMATION COULD BE OBTAINED. 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 |