BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2853856 · Received December 3, 2012

    Report

    Report Number
    3008382007-2012-06973
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    November 8, 2012
    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) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(6) ALLEGING THE METER WAS NOT POWERING ON. THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING DONE BY THE CCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3320292

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR