FDA Adverse Event
Malfunction
Summary report: N
CONTOUR LINK
MDR report key: 2994096
·
Received March 8, 2013
Report
- Report Number
- 1826988-2013-00081
- Event Type
- Malfunction
- Date Received
- March 8, 2013
- Date of Event
- February 13, 2013
- Report Date
- February 14, 2013
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K110587
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER RECEIVED A LOW OUT OF RANGE CONTROL RESULT OF 74 MG/DL ON THE CONTOUR LINK METER. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, WHICH WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. NO ADVERSE EVENT WAS ALLEGED. THE CUSTOMER DID NOT HAVE ACCESS TO THE CONTROL SOLUTION DURING THE CALL BUT THE METER INFORMATION WAS PROVIDED. NO PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 98970 | CONTOUR LINK | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE LLC | 6159 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |