BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO FLEX METER

    MDR report key: 6228101 · Received January 6, 2017

    Report

    Report Number
    3008382007-2017-00664
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Report Date
    December 25, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K150214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON 12/25/2016, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO A LAB DEVICE. THE REPORTER CLAIMED OBTAINING A BLOOD GLUCOSE READING OF ¿190 MG/DL¿ WITH THE SUBJECT METER AND ¿126 MG/DL¿ ON A LAB DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12396 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4031270

    Patients

    Seq Age Sex Outcome Treatment
    1