BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1162365 · Received September 9, 2008

    Report

    Report Number
    2939301-2008-02076
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PT ALLEGING THE ONE TOUCH ULTRALINK METER PROMPTED THE ERROR 3 MESSAGE. THE REPORTER STATED THE PT DID NOT DEVELOP ANY SYMPTOMS. THE PT TOOK HIS USUAL DOSE OF DIABETES MEDICATION DUE TO THE ISSUE. THE REPORTER MENTIONED THE PT DID NOT RECEIVE ANY MEDICAL INTERVENTION DUE TO THE ISSUE. THE PT'S TESTING TECHNIQUE WAS CORRECT. THE PRODUCT WAS NOT NEW (OUT OF BOX). THIS COMPLAINT IS BEING REPORTED BECAUSE THE ERROR 3 ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PRODUCT DID NOT CAUSE OR CONTRIBUTE TO INJURY BECAUSE THE PT DID NOT SUFFER ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1