BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO SYNC METER

    MDR report key: 3924623 · Received July 10, 2014

    Report

    Report Number
    2939301-2014-16966
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Report Date
    July 2, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K120708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN USA ALLEGING THAT THE CONTROL SOLUTION RESULTS WERE ABOVE THE EXPECTED CONTROL SOLUTION RANGE. THE PATIENT WAS UNSURE OF THE EXACT RESULTS OBTAINED. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405041 OT VERIO SYNC METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3572923

    Patients

    Seq Age Sex Outcome Treatment
    1