BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1162394 · Received September 9, 2008

    Report

    Report Number
    2939301-2008-02131
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Report Date
    August 25, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING INACCURATE CONTROL HIGH READINGS ON THE ULTRA LINK METER. THE PATIENT OBTAINED A 133 USING THE CONTROL SOLUTION AND CLAIMS THAT THE RESULT FELL OUT OF RANGE. THE PATIENT FELT SHAKY AT THE TIME OF TESTING. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION OR CONTACT THEIR PHYSICIAN FOR ASSISTANCE. THE TEST STRIPS WERE IN GOOD CONDITION AND NOT EXPIRED. CUSTOMER CARE ADVOCATE (CCA) WALKED THE PATIENT THROUGH A CONTROL TEST, AND THE TEST STRIPS STILL FELL OUT OF RANGE WITH THE CONTROL SOLUTION. CCA SENT THE PATIENT REPLACEMENT PRODUCTS. AT THIS TIME THERE IS NO EVIDENCE THAT THE METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT, SINCE THE PATIENT'S SYMPTOM OF FEELING JUST "SHAKY" IS NOT A SYMPTOM SUGGESTIVE OF HYPOGLYCEMIA. THE PATIENT DID NOT SEEK ANY MEDICAL INTERVENTION BASED ON THE SYMPTOM. THE COMPLAINT IS BEING REPORTED DUE TO THE INACCURATE CONTROL HIGH READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2843478

    Patients

    Seq Age Sex Outcome Treatment
    1