FDA Adverse Event
Malfunction
Summary report: N
CONTOUR NEXT EZ
MDR report key: 3802620
·
Received May 9, 2014
Report
- Report Number
- 1826988-2014-00162
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 17, 2014
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K111268
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER RECEIVED A BLOOD GLUCOSE READING OF 591MG/DL ON THE CONTOUR NEXT EZ METER, RE-TESTED ON A BREEZE2 METER AND THE READING WAS 84MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT NO ADVERSE EVENT WAS ALLEGED. THE CALL ENDED BEFORE ADDITIONAL INFORMATION COULD BE OBTAINED. PRODUCT WAS NOT REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281431 | CONTOUR NEXT EZ | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE LLC | 9628 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |