BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 4183438 · Received October 18, 2014

    Report

    Report Number
    2939301-2014-27938
    Event Type
    Malfunction
    Date Received
    October 18, 2014
    Report Date
    October 15, 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
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER (ONETOUCH VERIOIQ) READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE (CLINIC METER). THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE READINGS OF 246MG/DL WITH THE SUBJECT METER AND BETWEEN 83MG/DL ON ANOTHER DEVICE, BUT DID NOT SPECIFY THE TIME DIFFERENCE BETWEEN THE TESTS. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN¿S CRITERIA FOR ACCURACY. 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
    664103 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1