BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21311813 · Received February 5, 2025

    Report

    Report Number
    3003442380-2025-00633
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    December 31, 2024
    Report Date
    June 24, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018518
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6: INVESTIGATION RESULTS UNDER TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED). THE BATCH 6007838 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR BATCH 6007838 WERE PREVIOUSLY TESTED IN 2142417 ON 05/APR/2025. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2.0 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING THE LOT 6007838 WAS MANUFACTURED ACCORDING TO THE WI VERSION 97 AND PACKAGING IN THE MULTIVAC 14, ON 25/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. WELDING THE LOT 4F03729 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 19/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4E04741 WAS MANUFACTURED ACCORDING TO THE WI VERSION 34 WELDING IN THE MACHINE LS24 & LS25, ON 06/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. GLUING OF CONNECTOR THE LOT 4E03394 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 3, ON 19/MAY/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F02629 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 3, ON 13/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F04486 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 3, ON 22/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4E04731 WAS MANUFACTURED ACCORDING TO THE WI VERSION 37 IN THE GLUING OF CONNECTOR IN THE LINE 3, ON 06/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 18/JUN/2025 AGAINST MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6007838 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6007838 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE. NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CAPA PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS AT THE SITE. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53909 TRUSTEEL UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002836 6007838 05705244018518

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male