BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2930893 · Received January 28, 2013

    Report

    Report Number
    3008382007-2013-01631
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 4, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING WITH NO FAULTS FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY.LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING THAT THE SUBJECT METER READ INACCURATELY HIGH COMPARED TO OTHER DEVICES (OT ULTRA2 AND ANOTHER OT VERIOIQ). THE REPORTER WAS UNABLE TO PROVIDE THE SPECIFIC BLOOD GLUCOSE READINGS HE OBTAINED ON THE SUBJECT METER OR ON THE OTHER DEVICES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED INACCURACY ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36985 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3352097

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR