BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 21088854 · Received January 7, 2025

    Report

    Report Number
    3003442380-2024-36271
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 2, 2024
    Report Date
    November 7, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018426
    PMA / PMN Number
    K041545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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) WITH MALFUNCTION OCCLUSION AT INFUSION SITE (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED). THE BATCH 6003481 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 03 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 02 OCCLUSION AT INFUSION SITE (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED). COMPLAINT INVESTIGATION TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL (FLOW TEST) TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003481 WAS PACKAGED ACCORDING TO THE WI VERSION 94, PACKAGED IN THE MACHINE MULTIVAC 10, ON 01/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. WELDINGDEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 3J03241 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32, MANUFACTURED IN THE MACHINE LS24-LS25-LS11, ON 30/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 3J03232 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 29/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J03233 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35, MANUFACTURED IN THE MACHINE GLUING 3, ON 30/SEP/2023 WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 01/JUL/2025 AGAINST MALFUNCTION CODE EVALUATED OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6003481 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES RELATED TO THE COMPLAINT, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN EVENT OF OCCLUSION ALARM ON (B)(6) 2024. PATIENT REPORTED THAT THE OCCLUSION WAS AT THE SITE. BLOOD GLUCOSE LEVEL WAS 536 MG/DL AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION (MDI) FOR THE TREATMENT. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350435 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL UM-D 1002833 6003481 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Female