FDA Adverse Event
Malfunction
Summary report: N
CONTOUR NEXT USB
MDR report key: 5101054
·
Received September 24, 2015
Report
- Report Number
- 1826988-2015-00481
- Event Type
- Malfunction
- Date Received
- September 24, 2015
- Date of Event
- August 28, 2015
- Report Date
- September 3, 2015
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K121087
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IN SOME COUNTRIES OUTSIDE THE US, CUSTOMER INFORMATION IS NOT PROVIDED DUE TO PRIVACY LAWS.
Description of Event or Problem · 1
A (B)(6) CUSTOMER RECEIVED A BLOOD GLUCOSE RESULT OF 1.1MMOL/L ON THE CONTOUR NEXT USB. THE METER AUTOMATICALLY MARKED IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A CONTROL RESULT WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. STRIP INFORMATION WAS NOT PROVIDED. COUNTRY WAS ADVISED TO HAVE THE TEST STRIPS RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631811 | CONTOUR NEXT USB | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |