FDA Adverse Event
Malfunction
Summary report: N
CONTOUR
MDR report key: 1854406
·
Received September 29, 2010
Report
- Report Number
- 1826988-2010-00665
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 15, 2010
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- PMA / PMN Number
- K062058
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 212 MG/DL FROM ONE CONTOUR METER AND A READING OF 114 MG/DL FROM ANOTHER CONTOUR 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. CONTROL SOLUTION WAS SENT FOR FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR | NBW | BAYER HEALTHCARE, LLC | 7151B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |