FDA Adverse Event
Malfunction
Summary report: N
CONTOUR NEXT STRIPS
MDR report key: 2556295
·
Received April 24, 2012
Report
- Report Number
- 1826988-2012-00197
- Event Type
- Malfunction
- Date Received
- April 24, 2012
- Date of Event
- March 1, 2012
- Report Date
- March 21, 2012
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- PMA / PMN Number
- K111268
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
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
GERMAN SALES REPRESENTATIVE RECEIVED CONTROL TESTS OF 180, 176, 188, 148 MG/DL RANGE IS 118-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. STRIPS WERE REPLACED AND REPRESENTATIVE IS TO RETURN STRIPS FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR NEXT STRIPS | NBW | BAYER HEALTHCARE, LLC | 2AFEC01B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |