BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1193101 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02557
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    September 24, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 STIRPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    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 ULTRA LINK METER PROMPTED THE ERROR 4 MESSAGE ON THE METER DISPLAY. THE REPORTER DENIED THAT THE PT SUFFERED ANY SYMPTOMS, AND DENIED THAT THE PT SOUGHT MEDICAL ATTENTION. THE PT DID NOT TAKE ANY ACTION REGARDING DIABETES TREATMENT WITH REGARD TO THE ISSUE. THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE TEST STRIPS WERE WITHIN EXPIRATION DATING AND IN GOOD CONDITION. THE PRODUCT WAS NOT NEW. THIS COMPLAINT IS BEING REPORTED, BECAUSE THE ISSUE WAS NOT RESOLVED DURING TROUBLESHOOTING. THE PT DID NOT SUFFER ANY 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 2813149

    Patients

    Seq Age Sex Outcome Treatment
    1