BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO IQ METER

    MDR report key: 3974503 · Received August 3, 2014

    Report

    Report Number
    2939301-2014-19463
    Event Type
    Malfunction
    Date Received
    August 3, 2014
    Report Date
    July 28, 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
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 7/28/2014 FOLLOWING FINDINGS: THE TEST STRIP HAS PASSED TESTING FOR THE ALLEGED INACCURATE ISSUE. THE REPORTED ISSUE COULD NOT BE REPRODUCED. UNRELATED TO THE REPORTED ISSUE, THE TEST STRIPS WERE FOUND TO BE MISCUT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452416 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3638741

    Patients

    Seq Age Sex Outcome Treatment
    1