FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1070399
·
Received June 30, 2008
Report
- Report Number
- 2939301-2008-01248
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Report Date
- June 9, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT DISPLAY ISSUE OF CRACKING WAS UNRESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ONE TOUCH ULTRALINK METER | GLUCOSE MONITORING SYS/KIT | NBW | LIFESCAN, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |