BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 6078286 · Received November 4, 2016

    Report

    Report Number
    3008382007-2016-57111
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Report Date
    October 28, 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
    AU
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (ONE TOUCH ULTRA). THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿197, 150, 214, 232, 198, 296, 210, 186, 168, 118 AND 242 MG/DL¿ WITH THE SUBJECT METER AND ¿117, 102, 164, 151, 122, 211, 135, 139, 118, 85 AND 175 MG/DL¿ ON THE OTHER DEVICE RESPECTIVELY. THE TESTS WERE PERFORMED WITHIN AN UNKNOWN TIME 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
    731838 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3998085

    Patients

    Seq Age Sex Outcome Treatment
    1