BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 4910191 · Received July 7, 2015

    Report

    Report Number
    1314800-2015-00055
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 21, 2015
    Report Date
    July 7, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    KFZ
    PMA / PMN Number
    K103097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR INFANT. THE DEVICE ALLEGEDLY WAS READING 6.5 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT A HOSPITAL, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. NO ADVERSE EVENT OCCURRED, AND THE PATIENT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437693 BRAUN THERMOMETER KFZ KAZ USA, INC. IRT-3020 07814RAD

    Patients

    Seq Age Sex Outcome Treatment
    1 11 MO Hospitalization| O| R