BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN

    MDR report key: 3780955 · Received April 23, 2014

    Report

    Report Number
    1314800-2014-00031
    Event Type
    Other
    Date Received
    April 23, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 21, 2014
    Manufacturer
    KAZ, INC.
    Product Code
    FLL
    PMA / PMN Number
    K983295
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USING A WELCH ALLEN BLACK BODY THE IRT-3020 WAS RETESTED. THE BLACK BODY WAS SET TO 96.8 DEGREES FAHRENHEIT AND THE IRT-3020 WAS SET TO CAL MODE. THE TEMPERATURE OF THE BLACK BODY WAS TAKEN AND THE READING WAS 95.8 DEGREES FAHRENHEIT. THESE ARE FAILING RESULTS. THE THERMOMETER IS BEING SENT TO SUPPLIER FOR FURTHER EVAL.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT HIS THERMOMETER HAD GIVEN A FALSE NEGATIVE READING WHEN TAKING A TEMPERATURE ON THEIR CHILD. THE DEVICE WAS READING IN THE NORMAL RANGE DESPITE THE PATIENT HAVING A FEVER. THE CHILD WAS TAKEN TO THEIR PHYSICIAN, WHERE A FEVER WAS CONFIRMED. THERE WERE NO FURTHER COMPLICATIONS AND THE PATIENT IS DOING WELL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247097 BRAUN THERMOMETER FLL KAZ, INC. IRT-3020

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other