BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5909557 · Received August 28, 2016

    Report

    Report Number
    3008382007-2016-44129
    Event Type
    Malfunction
    Date Received
    August 28, 2016
    Report Date
    August 15, 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
    AZ, 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 LOW COMPARED TO ANOTHER DEVICE (ACCUCHEK). THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF ¿168, 222, 143 AND 247 WITH THE SUBJECT METER. THE REPORTER WAS UNABLE TO PROVIDE EXACT BLOOD GLUCOSE READING FROM THE OTHER DEVICE. 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
    561531 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4004786

    Patients

    Seq Age Sex Outcome Treatment
    1