BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3943153 · Received July 18, 2014

    Report

    Report Number
    2939301-2014-17780
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 10, 2014
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ¿ (09/15/2014). THE LAY USER/PATIENT¿S PRODUCTS HAVE BEEN RETURNED, AND WERE EVALUATED ON 09/10/2014 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE REPORTED ISSUE COULD NOT BE CONFIRMED. HOWEVER, A SECONDARY ISSUE UNRELATED TO THE COMPLAINT WAS FOUND, THE RETURNED TEST STRIP VIAL CONTAINED EXTRA TEST STRIPS. 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) 2014, THE REPORTER CONTACTED LIFESCAN (B)(6), ALLEGING ERROR UNKNOWN. 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
    421614 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3611747

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR