BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 6574621 · Received May 18, 2017

    Report

    Report Number
    3008382007-2017-21193
    Event Type
    Malfunction
    Date Received
    May 18, 2017
    Report Date
    April 26, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008402
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATE RESULTS OF 212, 137, 167, 200, 172, 192, 107, 153 AND 199MG/DL USING THE SUBJECT DEVICE WITHIN 20 MINUTES OF EACH OTHER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED RESULTS DID NOT MEET LIFESCAN¿S ACCURACY/PRECISION 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
    356010 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4115492 00353885008402

    Patients

    Seq Age Sex Outcome Treatment
    1