FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1210228
·
Received October 20, 2008
Report
- Report Number
- 2939301-2008-02719
- Event Type
- Malfunction
- Date Received
- October 20, 2008
- Report Date
- October 13, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE LFS PRODUCTS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCTS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCTS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM THE FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PT ALLEGING THAT THE PRODUCT DISPLAY ISSUE OF BLACK MARKS 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 | 2840780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |