BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19936607 · Received August 8, 2024

    Report

    Report Number
    3003442380-2024-19589
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    June 20, 2024
    Report Date
    November 15, 2025
    Manufacturer
    UNOMEDICAL A/S
    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. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003269, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003269 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGING IN THE MULTIVAC M10 ON 12-SEP-2023, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. THE SUB-ASSEMBLY: GLUING OF TUBING LOT 3J01207 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC05-SC06, ON 11-SEP-2023, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR 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 INFUSION SET BLOCKAGE LOCATED IN THE TUBING EVENT ON 20-JUN-2024. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS HIGH AND THE PATIENT RESOLVED IT WITH CORRECTION BOLUS VIA PUMP FOLLOWED BY CHANGING SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617632 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6003269 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female