BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO SYNC METER

    MDR report key: 5143233 · Received October 10, 2015

    Report

    Report Number
    2939301-2015-43343
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Report Date
    September 22, 2015
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K120708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER READ INACCURATE COMPARED TO A FREESTYLE METER. THE REPORTER WAS UNABLE TO GIVE EXACT VALUES. THE TESTS WERE PERFORMED WITHIN AN UNKNOWN TIME OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING, SINCE WE COULD NOT CONFIRM THAT THE CALCULATED DIFFERENCE EXCEEDED OUR CRITERIA AS NO VALUES WERE GIVEN. 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
    673060 OT VERIO SYNC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1