FDA Adverse Event
Other
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1051808
·
Received May 23, 2008
Report
- Report Number
- 2939301-2008-00910
- Event Type
- Other
- Date Received
- May 23, 2008
- Report Date
- May 22, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE LAY USER/PATIENT'S FATHER CONTACTED LIFESCAN ALLEGING THAT THE DISPLAY ON HIS DAUGHTER'S NEW ONETOUCH ULTRALINK METER WAS "TOO LIGHT TO READ." THE ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. THERE WAS 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 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |