BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 20264346 · Received September 20, 2024

    Report

    Report Number
    3003442380-2024-26257
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 10, 2024
    Report Date
    November 20, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018457
    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. REVISION 21 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 6001891, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6001891 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 93 AND MANUFACTURED IN THE MACHINE MULTIVAC 10 ON 21/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR LOT: THE LOT 3F01786 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 15/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03303 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 20/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03304 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 20/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03305 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 23/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03306 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 23/JUN/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3F03323 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 AND MANUFACTURED IN THE MACHINE MP03 ON 20/JUN/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. 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

    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. ON 10-AUG-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET OCCLUSION AT SITE. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469042 TRUSTEEL UNO CONTACT DETACH G29 80/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002834 6001891 05705244018457

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male