BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO2 METER

    MDR report key: 5143055 · Received October 10, 2015

    Report

    Report Number
    2939301-2015-43306
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Report Date
    September 21, 2015
    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
    CA, 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 WAS READING INACCURATELY IN COMPARISON WITH THEIR FEELINGS OR NORMAL RESULTS. THE PATIENT REPORTED RESULTS OF "110, 163, 221, 229, 136, 185, 245, 71, 194, 165, 22 AND 122MG/DL" ON THE SUBJECT METER. DURING THE CALL THE PATIENT PERFORMED A CONTROL SOLUTION TEST AND THE RESULTS WERE NOT IN RANGE, THEREFORE 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
    672926 OT VERIO2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3839182

    Patients

    Seq Age Sex Outcome Treatment
    1