BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3851615 · Received June 5, 2014

    Report

    Report Number
    2939301-2014-13482
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    June 3, 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
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULT OF 198MG/DL WHEN COMPARED TO ANOTHER METER THAT READ 148MG/DL PERFORMED WITHIN 30 MINUTES. IN ADDITION, THE REPORTER CLAIMED THAT THE SUBJECT DEVICE READ 50, 52, 55, 54 (MG/DL) HIGHER THAN THE OTHER DEVICE (FREESTYLE). THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY CRITERIA AND 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
    328917 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3515633

    Patients

    Seq Age Sex Outcome Treatment
    1