BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3183426 · Received June 22, 2013

    Report

    Report Number
    3008382007-2013-18001
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    June 11, 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
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING INACCURATE RESULTS. THE REPORTER ALLEGED INACCURATE HIGH RESULTS. THE REPORTER CLAIMED OBTAINING BLOOD GLUCOSE RESULTS OF ¿ALWAYS HIGHER THAN OT ULTRA METER¿ WITH A VERIO IQ METER AND ¿ALWAYS LOWER THAN VERIO IQ METER¿ ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284438 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3242231

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR