BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4120388 · Received September 26, 2014

    Report

    Report Number
    2939301-2014-25417
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 1, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO THE PATIENT'S FEELINGS/NORMAL RESULTS. WHEN THE CUSTOMER CARE ADVOCATE WALKED THE PATIENT THROUGH A CONTROL SOLUTION TEST, THE CONTROL SOLUTION WAS NOT IN RANGE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601802 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3656704

    Patients

    Seq Age Sex Outcome Treatment
    1