BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1220832 · Received October 30, 2008

    Report

    Report Number
    2939301-2008-02867
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Report Date
    October 17, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER FOR EVALUATION, BUT HAS NOT YET RECEIVED IT. IF THE METER IS RETURNED, LIFESCAN WILL EVALUATE IT AND, IF THE METER DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LFS ALLEGING AN APPLY SAMPLE MESSAGE ON THEIR ONE TOUCH ULTRALINK METER. THE PT DID NOT EXHIBIT ANY SYMPTOMS OR SEEK ANY MEDICAL ATTENTION DUE TO THE REPORTED ISSUE. THE PT TOOK HIS USUAL DOSAGE OF DIABETES MEDICATION. THE TECHNIQUE OF APPLYING BLOOD ON THE TEST STRIP WAS CORRECT. THE PT RETESTED USING A NEW VIAL AND ISSUE PERSISTED. THE METER IS NOT A NEW PRODUCT. METER WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION. THE COMPLAINT IS BEING REPORTED DUE TO THE ALLEGED ISSUE WITH THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2796592

    Patients

    Seq Age Sex Outcome Treatment
    1