FDA Adverse Event
Malfunction
Summary report: N
OT ULTRALINK METER
MDR report key: 2213584
·
Received August 16, 2011
Report
- Report Number
- 2939301-2011-07518
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Report Date
- August 1, 2011
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THERE WERE NO PRODUCT(S) REQUESTED FOR RETURN FOR EVALUATION. IF ANY PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE LANCING DEVICE MISSING WAS NOT RESOLVED WITH TROUBLESHOOTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OT ULTRALINK METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN INC. | 3094406 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |