BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 6506585 · Received April 20, 2017

    Report

    Report Number
    3008382007-2017-18416
    Event Type
    Malfunction
    Date Received
    April 20, 2017
    Report Date
    April 4, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING INACCURATELY HIGH CONTROL SOLUTION RESULTS. THE REPORTER OBTAINED CONTROL SOLUTION READINGS OF "150, 152 AND 170MG/DL" ON THE SUBJECT METER. THIS FALLS OUT WITH THE CONTROL SOLUTION RANGE OF "102-138MG/DL" FOR THIS STRIP LOT. 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
    291418 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 00353885008402

    Patients

    Seq Age Sex Outcome Treatment
    1