BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19772107 · Received July 18, 2024

    Report

    Report Number
    3003442380-2024-14750
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    February 1, 2024
    Report Date
    October 17, 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 - PER REVISION (B)(4) OF PROCEDURE (B)(4), A CHILD INVESTIGATION IS NOT REQUIRED TO DOCUMENT THE DHR REVIEW FOR A TYPE 2 REPORTABLE COMPLAINT. HOWEVER, THE CHILD WAS CREATED TO ALLOW THE PARENT RECORD TO ADVANCE TO REVIEW AND SUMMARY. SINCE IT WAS CREATED, THE DHR REVIEW WAS DOCUMENTED WITHIN THE CHILD. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003584, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003584 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGING IN THE MACHINE MULTIVAC 10 ON 08-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3J04190 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 32 AND MANUFACTURED IN THE MACHINE LS11-LS24-LS25, ON 06-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3J01993 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 32 AND MANUFACTURED IN THE MACHINE LS11, ON 16-SEP-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3J04161 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35 AND MANUFACTURED IN THE GLUING 3, ON 06-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3K02288 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35 AND MANUFACTURED IN THE GLUING 3, ON 13-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3J01992 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35 AND MANUFACTURED IN THE GLUING 3, ON 16-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 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 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

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 01-FEB-2024, IT WAS REPORTED THAT THE PATIENT FACED THAT THE INFUSION SET BLOCKAGE WAS LIKELY AT THE SITE. THE PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION 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
    215859 TRUSTEEL UNO CONTACT DETACH G29 80/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002836 6003584 05705244018518

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male