FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1051968
·
Received May 22, 2008
Report
- Report Number
- 2939301-2008-00889
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 28, 2008
- Report Date
- May 16, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THAT HIS NEW ONE TOUCH ULTRALINK METER WAS NOT DISPLAYING HIS BEFORE AND AFTER MEAL AVERAGES, WHICH 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |