BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRA2 METER

    MDR report key: 8784430 · Received July 12, 2019

    Report

    Report Number
    3008382007-2019-02769
    Event Type
    Malfunction
    Date Received
    July 12, 2019
    Report Date
    July 8, 2019
    Manufacturer
    LIFESCAN EUROPE GMBH
    Product Code
    NBW
    UDI-DI
    00353885008372
    PMA / PMN Number
    K053529
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE REPORTER CONTACTED LIFESCAN UNITED STATES, ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO A LABORATORY DEVICE. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿212 MG/DL¿ WITH THE SUBJECT METER AND ¿87 MG/DL ¿ ON THE LABORATORY DEVICE. THE TESTS WERE PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577643 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE GMBH 00353885008372

    Patients

    Seq Age Sex Outcome Treatment
    1