BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPLE TOUCH PRO SENSOR UNIT, NON-INVASIVE CORE TEMP MONT

    MDR report key: 21835026 · Received April 14, 2025

    Report

    Report Number
    1043214-2025-00002
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 11, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MEDISIM LTD.
    Product Code
    FLL
    PMA / PMN Number
    K150160
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDWATCH WAS RECEIVED FROM A UNKNOWN DEROYAL CUSTOMER STATING, THE TEMPLE TOUCH PRO DEVICE WAS NOT MEASURING THE PATIENT'S TEMPERATURE ACCURATELY. THIS WAS CONFIRMED BY THE PATIENT AND ANOTHER TEMPERATURE DEVICE THAT DIFFERED FROM THE TEMPLE TOUCH PRO." NO INITIAL REPORTING INFORMATION INCLUDING NAME OR FACILITY WAS GIVEN. DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE. BECAUSE THIS IS A PURCHASED PRODUCT, DEROYAL DID NOT HAVE SPECIFICATIONS OR RISK ANALYSIS TO REVIEW. INVENTORY WAS UNABLE TO BE CHECKED AS NO INVENTORY WAS PRESENT. DEROYAL ALSO WORKED WITH CUSTOMERS TO RE-TRAINED ON USE OF THE TTP AND HOW TO APPLY TO GET ACCURATE READINGS. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER. BECAUSE THE PRODUCT WAS UNAVAILABLE FOR RETURN, THE SUPPLIER WAS UNABLE TO PERFORM AN ENTIRE INVESTIGATION. ROOT CAUSE: BECAUSE NO SAMPLE WAS AVAILABLE FOR RETURN AND NO ISSUES COULD BE FOUND WITHIN THE INVESTIGATION, NO ROOT CAUSE WAS ABLE TO BE DETERMINED. CORRECTIVE OR PREVENTIVE ACTIONS: BECAUSE NO ROOT CAUSE COULD BE DETERMINED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A MEDWATCH WAS RECEIVED FROM A UNKNOWN DEROYAL CUSTOMER STATING, THE TEMPLE TOUCH PRO DEVICE WAS NOT MEASURING THE PATIENT'S TEMPERATURE ACCURATELY. THIS WAS CONFIRMED BY THE PATIENT AND ANOTHER TEMPERATURE DEVICE THAT DIFFERED FROM THE TEMPLE TOUCH PRO." NO INITIAL REPORTING INFORMATION INCLUDING NAME OR FACILITY WAS GIVEN. DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS UNAVAILABLE. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN ISSUED TO THE SUPPLIER. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED, "THE TEMPLE TOUCH PRO DEVICE WAS NOT MEASURING THE PATIENT'S TEMPERATURE ACCURATELY. THIS WAS CONFIRMED BY THE PATIENT AND ANOTHER TEMPERATURE DEVICE THAT DIFFERED FROM THE TEMPLE TOUCH PRO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989656 TEMPLE TOUCH PRO SENSOR UNIT, NON-INVASIVE CORE TEMP MONT THERMOMETER, ELECTRONIC, CLINICAL FLL MEDISIM LTD. 81-1020SU 0482024

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown