BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAUN

    MDR report key: 5165671 · Received October 7, 2015

    Report

    Report Number
    1314800-2015-00069
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Report Date
    October 7, 2015
    Manufacturer
    KAZ USA, INC.
    Product Code
    FLL
    PMA / PMN Number
    K103097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: AFTER CLEANING, ALL READINGS ARE WITHIN SPECIFICATION. THESE ARE PASSING RESULTS. THE CAUSE OF THE FALSE NEGATIVE READING WAS A DIRTY LENS. THE INSTRUCTIONS FOR PROPER USE STATE THAT THE THERMOMETER SHOULD BE CLEANED IN BETWEEN USES, AS NECESSARY.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS ON THEIR CHILD FOR SEVERAL DAYS. THE DEVICE ALLEGEDLY WAS READING 3-4 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT A (B)(6) FACILITY WHERE IT WAS CONFIRMED THAT THEY HAD A FEVER. THERE WERE NO COMPLICATIONS FROM THIS INCIDENT, AND THE PT IS DOING FINE NOW. KAZ USA, INC HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664415 BRAUN THERMOMETER FLL KAZ USA, INC. IRT-3020 24313RAD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R