FDA Adverse Event
Malfunction
Summary report: N
CONTOUR
MDR report key: 1960171
·
Received December 15, 2010
Report
- Report Number
- 1826988-2010-00851
- Event Type
- Malfunction
- Date Received
- December 15, 2010
- Date of Event
- December 5, 2010
- Report Date
- December 7, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND RECEIVED READINGS OF 338, 308 AND 256 MG/DL. HER GLUCOSE WAS RETESTED USING ANOTHER METER AND THOSE READINGS OF 120 AND 130 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CONTROL SOLUTION WAS SENT TO THE CUSTOMER 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 |