FDA Adverse Event
Injury
Summary report: N
CONTOUR NEXT LINK
MDR report key: 4122639
·
Received September 26, 2014
Report
- Report Number
- 1826988-2014-00334
- Event Type
- Injury
- Date Received
- September 26, 2014
- Date of Event
- September 1, 2014
- Report Date
- September 5, 2014
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- NBW
- PMA / PMN Number
- K110894
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER HAD AN INCIDENT WHERE SHE WAS STOPPED BY THE POLICE BECAUSE SHE WAS DRIVING ERRATICALLY. SHE WAS ALSO INCOHERENT. SHE TESTED HER BLOOD GLUCOSE ON THE CONTOUR NEXT LINK AND THE READING WAS 124MG/DL. THE POLICE REQUESTED AN AMBULANCE AND THE EMT RETESTED HER WITH ANOTHER METER. THE READING WAS 33MG/DL. CUSTOMER WAS GIVEN LIQUID GLUCOSE THREE TIMES AND THEN FELT BETTER. A REPLACEMENT METER WAS SENT TO HER. ONLY THE METER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 602023 | CONTOUR NEXT LINK | BLOOD GLUCOSE METER | NBW | BAYER HEALTHCARE LLC | 9632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |