BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO METER

    MDR report key: 2866910 · Received December 11, 2012

    Report

    Report Number
    3008382007-2012-07528
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Report Date
    November 15, 2012
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K093745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME HAS BEEN CORRECTED TO ONE TOUCH VERIO IQ METER. 510K# IS K110637.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(6) ALLEGING THE METER WAS DISPLAYING A BATTERY INDICATOR THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVE WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA). THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR