BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1162366 · Received September 9, 2008

    Report

    Report Number
    2939301-2008-02088
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR TEST STRIPS ARE RETURNED, LIFESCAN WILL EVAL THEM.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THE ONE TOUCH ULTRALINK METER WAS GIVING THE ERROR 5 ERROR MESSAGE. THE PT EXPERIENCED NO SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND DID NOT SEEK ANY MEDICAL ATTENTION. DURING THE TROUBLESHOOTING TELEPHONE CALL, THE CUSTOMER CARE ADVOCATE (CCA) DETERMINED THE PT'S TEST STRIPS WERE IN GOOD CONDITION AND WITHIN OPENED EXPIRATION DATING AND THE PT'S TESTING TECHNIQUE WAS CORRECT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THE METER WAS REPLACED. THE PT DID NOT SUFFER ANY INJURY DUE TO THE REPORTED METER. THE PT EXPERIENCED NO SYMPTOMS AND DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE ERROR 5 ERROR MESSAGE ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2852464

    Patients

    Seq Age Sex Outcome Treatment
    1