BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19772089 · Received July 18, 2024

    Report

    Report Number
    3003442380-2024-14978
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    May 16, 2024
    Report Date
    October 29, 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

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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 (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 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 MANUFACTURED IN THE MACHINE MULTIVAC 10 ON 12/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. GLUE-CONNECTOR LOT: THE LOT 3J01198 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 09/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J01199 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 10/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J01293 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 11/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J00211 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 02/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE LOT 3J00212 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 35 AND MANUFACTURED IN THE MACHINE MP03 ON 03/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT, ONE NON-CONFORMANCE (NC) WAS FOUND WITH NUMBER 1737591, DISCREPANCY BETWEEN THE IFU (INS-910-2) IMPLEMENTED VS THE INITIAL SCOPE AND IMPACT ASSESSMENT OF THE CCR FOR AUTOSOFT XC AND WOMBAT. THEREFORE, THE DHR CONFIRMS THAT ALL REQUIRED TESTS RELATED TO THE PROCESS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO 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 MALFUNCTION CODE, THEREFORE, 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 THE UNITED STATES. ON 16-MAY-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING WAS LEAKING AT ON TOP OF CARTRIDGE. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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
    215861 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6003269 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male