FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA CONTOUR
MDR report key: 677304
·
Received February 8, 2006
Report
- Report Number
- 1826988-2006-00078
- Event Type
- Malfunction
- Date Received
- February 8, 2006
- Date of Event
- January 13, 2006
- Report Date
- January 13, 2006
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT SHE HAD A SPECIFIC BOTTLE OF TEST STRIPS THAT SHE FELT WERE NOT ACCURATE. THE NORMAL CONTROL RANGE WAS 85-114MG/DL AND SHE GOT RESULTS OF 123, 125 AND 163MG/DL. SHE TESTED ON 3 OTHER BOTTLES OF STRIPS AND ALL RESULTS WERE WITHIN RANGE. NO ACTUAL NUMBERS WERE GIVEN. CUSTOMER SERVICE WAS GOING TO REPLACE THE STRIPS AND ADVISED THEY BE SENT BACK TO BE EVALUATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA CONTOUR | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE LLC | 7151 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |