FDA Adverse Event
Malfunction
Summary report: N
ONE TOUCH ULTRALINK METER
MDR report key: 1051977
·
Received May 22, 2008
Report
- Report Number
- 2939301-2008-00898
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Report Date
- May 20, 2008
- Manufacturer
- LIFESCAN, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
THE LAY USER/ PT CONTACTED LIFESCAN ALLEGING THAT THE PRODUCT WAS READING INACCURATE HIGH WHEN A CONTROL SOLUTION TEST WAS DONE. THE CUSTOMER CARE ADVOCATE WALKED THE LAY USER THROUGH CONTROL SOLUTION TEST, AND THE RESULTS FELL OUTSIDE THE SPECIFIED CONTROL SOLUTION RANGE. THE PT'S CONTROL SOLUTION AND THE TEST STRIPS WERE REPLACED. 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 | 2817816 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |