BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3003221 · Received March 14, 2013

    Report

    Report Number
    3008382007-2013-04982
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 16, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K110637
    Removal / Correction Number
    2012-012-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(4), ALLEGING THE METER WAS REVERTING TO THE SET UP MODE. THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107272 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR