BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3020450 · Received March 26, 2013

    Report

    Report Number
    3008382007-2013-06203
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 26, 2013
    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
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN, ALLEGING INACCURATE RESULTS. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF 123 MG/DL WITH A LIFESCAN METER AND 103 MG/DL ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED LIFESCAN¿S CRITERIA FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123729 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3330298

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR