BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2152663 · Received July 7, 2011

    Report

    Report Number
    3008382007-2011-00008
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    May 20, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CONTACTED LIFESCAN (B)(4) ALLEGING AN UNKNOWN ISSUE WITH THE ONETOUCH VERIOPRO METER. THE PATIENT WAS UNABLE TO GO THROUGH TROUBLESHOOTING WITH CUSTOMER SERVICE SINCE THE REPORTED METER WAS GIVEN BACK TO THE SALES REPRESENTATIVE. LIFESCAN RECEIVED THE METER INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION. THIS COMPLAINT IS BEING REPORTED BECAUSE INVESTIGATION REVEALED THAT THE METER WAS NOT POWERING OFF IMMEDIATELY AFTER REMOVING THE STRIP, WHICH WAS OCCURRING DUE TO AN INCORRECT SETTING IN THE METER'S SOFTWARE. THERE WAS NO ALLEGATION OF HARM OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1