FDA Adverse Event
Malfunction
Summary report: N
OT ULTRALINK METER
MDR report key: 2013790
·
Received March 10, 2011
Report
- Report Number
- 2939301-2011-02055
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Report Date
- March 6, 2011
- Manufacturer
- LIFESCAN INC.
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K)# IS K073231.
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 THE METER DISPLAY HAS SEGMENTS MISSING AND BLACK MARKS. THESE ISSUES WERE 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. | 3053685 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |