FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1071482
·
Received July 2, 2008
Report
- Report Number
- 2939301-2008-01288
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Report Date
- June 16, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM 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/PATIENT ALLEGING THAT THE PRODUCT HAD THE FOLLOWING PRODUCT CASING ISSUE: CRACKED DISPLAY. 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 | 2825935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |