BEUDAMED
    FDA Adverse Event Other Summary report: N

    BRAUN

    MDR report key: 4863452 · Received June 18, 2015

    Report

    Report Number
    1314800-2015-00048
    Event Type
    Other
    Date Received
    June 18, 2015
    Date of Event
    May 13, 2015
    Report Date
    June 17, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ISSUE CAN BE REPRODUCED AND ALL THREE READINGS ARE TO LOW AND OUT OF SPECIFICATION. A SECOND TEST HAS BEEN DONE AFTER HAVING CLEANED THE LENS ON THE PROBE-TIP AND AGAIN IN CALIBRATION MODE. FINDINGS: BLACK BODY SETTING C CELSIUS; 36.0/ IRT-3020 C; 36.0 CELSIUS, BLACK BODY SETTING C CELSIUS; 38.5 & IRT-3020 C; 38.5. BLACK BODY SETTING C CELSIUS; 41.0 & IRT-3020 C; 41.0.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR CHILD. THE DEVICE ALLEGEDLY WAS READING 6.1 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD SUFFERED A SEIZURE AND WAS TREATED AT A HOSPITAL, WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395783 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-3020 34112RAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization