FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1106901
·
Received August 6, 2008
Report
- Report Number
- 2939301-2008-01753
- Event Type
- Malfunction
- Date Received
- August 6, 2008
- Report Date
- July 23, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE IT 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 WAS READING INACCURATE, ERRATIC. THE CUSTOMER CARE ADVOCATE WALKED THE LAY USER THROUGH CONTROL SOLUTION TESTS AND THE RESULTS FELL OUTSIDE THE SPECIFIED CONTROL SOLUTION RANGE. 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 | 2824394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |