BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2924436 · Received January 22, 2013

    Report

    Report Number
    3008382007-2013-01254
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE METER PASSED TESTING; NO FAULTS WERE FOUND. THE METER WAS FOUND TO FUNCTION PROPERLY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING METER REVERTING TO SETUP MODE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED 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
    31058 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3326378

    Patients

    Seq Age Sex Outcome Treatment
    1