BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 2905777 · Received January 9, 2013

    Report

    Report Number
    3008382007-2013-00477
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 15, 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, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT METER AND TEST STRIPS HAVE BEEN RETURNED TO LIFESCAN FOR EVALUATION. THE EVALUATION OF THE PRODUCTS HAVE NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE REPORTED COMPLAINT WAS OBSERVED ON THE METER'S ERROR LOG; HOWEVER, PA WAS UNABLE TO REPRODUCE FAILURE IN METER TESTING. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE EVALUATED AND ER4 WAS OBSERVED WITH CONTROL SOLUTION TESTING. 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)(6) 2012, THE REPORTER CONTACTED LIFESCAN (LFS) IN THE USA ALLEGING THE METER WAS DISPLAYING AN ERROR 4 MESSAGE. 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
    12421 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1