BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1051904 · Received May 23, 2008

    Report

    Report Number
    2939301-2008-00906
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Report Date
    May 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    LAY USER/PATIENT
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT STRIPS FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF THE STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE 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 PT CONTACTED LIFESCAN ALLEGING THAT THE PROD WAS READING INACCURATELY HIGH WHEN A CONTROL SOLUTION TEST WAS DONE. WHEN THE CUSTOMER CARE ADVOCATE (CCA) WALKED THE LAY USER THROUGH CONTROL SOLUTION TEST, THE RESULTS WERE NOT WITHIN THE SPECIFIED CONTROL SOLUTION RANGE BUT WHEN RETESTED WITH A NEW VIAL OF TEST STRIPS, THE RESULTS CAME WITHIN THE SPECIFIED RANGE. DURING THE TROUBLESHOOTING, THE CCA FOUND OUT THAT THE PT WAS USING THE CORRECT TESTING TECHNIQUE AND THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE PT'S TEST STRIPS WERE REPLACED. THERE WERE NO ALLEGATIONS OF HARM OR 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 2810415

    Patients

    Seq Age Sex Outcome Treatment
    1 Female