BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5771319 · Received July 6, 2016

    Report

    Report Number
    3008382007-2016-34057
    Event Type
    Malfunction
    Date Received
    July 6, 2016
    Report Date
    June 27, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K131363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (ULTRAMINI). THE REPORTER CLAIMED RECEIVED BLOOD GLUCOSE READINGS OF "130, 137 AND 182 MG/DL" WITH THE SUBJECT METER BUT WAS UNABLE TO PROVIDE READINGS FOR THE OTHER DEVICE. THE TESTS WERE PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE RESULTS MAY NOT HAVE MET LIFESCAN'S ACCURACY CRITERIA AND THE ALLEGED INACCURACY 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
    428188 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4004785

    Patients

    Seq Age Sex Outcome Treatment
    1