BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO FLEX METER

    MDR report key: 6259492 · Received January 18, 2017

    Report

    Report Number
    3008382007-2017-02858
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Report Date
    January 11, 2017
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K150214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING AN UNUSUAL ISSUE WITH THE SUBJECT METER. THE REPORTER CLAIMED THAT THEY WERE RECEIVING A "LO E" MESSAGE WHEN POWERING ON THE DEVICE. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME. 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
    44073 OT VERIO FLEX METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1