BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 3050923 · Received April 10, 2013

    Report

    Report Number
    3008382007-2013-07469
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 13, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED LIFESCAN (LFS) IN (B)(4) ALLEGING THE METER WAS DISPLAYING A BATTERY INDICATOR. THERE WAS NO INDICATION THAT THE LFS PRODUCT CAUSED OR CONTRIBUTED TO A ADVERSE EVENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING DONE BY THE CUSTOMER CARE ADVOCATE (CCA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149755 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3261093

    Patients

    Seq Age Sex Outcome Treatment
    1