FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA CONTOUR
MDR report key: 1163644
·
Received September 9, 2008
Report
- Report Number
- 1826988-2008-00995
- Event Type
- Malfunction
- Date Received
- September 9, 2008
- Date of Event
- August 17, 2008
- Report Date
- August 17, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE ADVOCATE CALLED FOR HELP WITH THE CUSTOMER'S METER. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS USING 2 BOTTLES OF TEST STRIPS AND RECEIVED RESULTS OF 202 AND 216 MG/DL. THE NORMAL CONTROL RANGES WERE 103-142 MG/DL AND 103-143 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER USED THE LAST OF THE TEST STRIPS, SO THEY ARE NOT AVAILABLE FOR EVALUATION. THE METER IS TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASCENSIA CONTOUR | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE, LLC | 7151B | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |