BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1193092 · Received October 6, 2008

    Report

    Report Number
    2939301-2008-02552
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Report Date
    September 11, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, 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

    IN 2008 THE LAY USER/REPORTER CONTACTED LIFESCAN ON BEHALF OF THE LAY USER/PATIENT ALLEGING THE ERROR 2 MESSAGE APPEARED ON THE DISPLAY OF THE ONE TOUCH ULTRA LINK METER. THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY SYMPTOMS, AND DENIED THAT THE PATIENT SOUGHT MEDICAL ATTENTION. THE PATIENT DID NOT TAKE ANY ACTION REGARDING DIABETES TREATMENT DUE TO THE ISSUE. THE PATIENT'S TESTING TECHNIQUE WAS CORRECT. THE ERROR 2 OCCURS WHEN INSERTING THE TEST STRIP. THE TEST STRIPS WERE IN GOOD CONDITION AND THE ISSUE WAS NOT RESOLVED UPON RETEST. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT DID NOT DEVELOP 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 2830968

    Patients

    Seq Age Sex Outcome Treatment
    1