BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1051984 · Received May 22, 2008

    Report

    Report Number
    2939301-2008-00838
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    May 12, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR 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 PROMPTING AN ERROR MESSAGE, BUT HE DOES NOT KNOW WHICH ERROR MESSAGE THE METER WAS PROMPTING. THE ISSUE WAS UNRESOLVED WITH TROUBLESHOOTING. THE PT'S PRODUCTS ARE BEING 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 2807188

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK