BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARC INSTATEMP

    MDR report key: 7343371 · Received March 15, 2018

    Report

    Report Number
    3011197139-2018-00005
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Date of Event
    February 15, 2018
    Report Date
    March 15, 2018
    Manufacturer
    ARC DEVICES USA INC.
    Product Code
    FLL
    PMA / PMN Number
    K152905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE THERMOMETER DID NOT REGISTER A FEVER. THE CUSTOMER TOOK HER SON TO URGENT CARE WHERE THE TEMPERATURE WAS REPORTED TO READ (B)(6). THERE WERE NO REPORTED COMPLICATIONS FROM THIS INCIDENT. ARC REQUESTED AND RECEIVED THE RETURNED DEVICE. UPON INVESTIGATION, THE PROBLEM WAS VERIFIED. NO OTHER COMPLAINTS OF THIS TYPE HAVE BEEN VERIFIED. NO ROOT CAUSE COULD BE CONFIRMED. THIS PROBLEM WILL CONTINUE TO BE MONITORED AND TRENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186629 ARC INSTATEMP THERMOMETER, FLL ARC DEVICES USA INC. CF1-0196

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR