BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH ULTRALINK METER

    MDR report key: 1122106 · Received August 14, 2008

    Report

    Report Number
    2939301-2008-01877
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Report Date
    August 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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/PT CONTACTED LFS ALLEGING INACCURATE HIGH READINGS ON THE ULTRALINK METER. THE PT OBTAINED AN 85 MG/DL ON THE LFS METER AND COMPARED IT TO THE LAB RESULT OF 57 MG/DL WITHIN 10 MINS OF ONE ANOTHER. THE PT DID NOT EXHIBIT ANY SYMPTOMS AND DID NOT RECEIVE ANY MEDICAL TREATMENT. THE PT WAS UNABLE/UNWILLING TO VERIFY WHETHER THE TEST STRIPS HAD BEEN OPENED LONGER THAN THE EXPIRATION DATE, WHETHER THE TEST STRIP VIAL WAS CRACKED OR BROKEN, THE CONDITION OF THE TEST STRIPS. PT HAD CONTROL SOLUTION; HOWEVER, PT WAS UNABLE/UNWILLING TO RUN A QUALITY CONTROL TEST. METER WAS REPLACED. BETWEEN THE TESTS, THERE WAS NO INTERVENTION THAT WOULD BE EXPECTED TO CHANGE THE BLOOD GLUCOSE. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1