BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 6184725 · Received December 19, 2016

    Report

    Report Number
    3008382007-2016-64955
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    December 11, 2016
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    UDI-DI
    00353885008402
    PMA / PMN Number
    K110637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT¿S TEST STRIPS HAVE BEEN EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS FAILED TESTING. THE REPORTED ISSUE WAS CONFIRMED; WHEN THE TEST STRIPS WERE TESTED WITH CONTROL SOLUTION, AN ERROR 4 WAS OBSERVED WITH NO ASSIGNABLE CAUSE FOUND. 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) 2016, THE REPORTER CONTACTED LIFESCAN USA, 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
    837875 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 4040875 00353885008402

    Patients

    Seq Age Sex Outcome Treatment
    1