FDA Adverse Event
Malfunction
Summary report: N
ASCENSIA CONTOUR
MDR report key: 1030377
·
Received April 15, 2008
Report
- Report Number
- 1826988-2008-00427
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 28, 2008
- Report Date
- March 28, 2008
- Manufacturer
- BAYER HEALTHCARE, LLC
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT CONTROL TESTS WERE PERFORMED USING HIS CONTOUR METER. HE ALLEGED THAT HE RECEIVED RESULTS THAT WERE 40 MG/DL LOW, OUT OF SPECIFICATION. THE CUSTOMER DID NOT PROVIDE ACTUAL RESULTS OR ANY TEST STRIP INFO. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DECLINED TROUBLESHOOTING AND INSISTED HIS METER BE REPLACED. THE CUSTOMER'S METER IS TO BE RETURNED FOR EVAL.
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 |