BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22041763 · Received May 19, 2025

    Report

    Report Number
    3003442380-2025-09071
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    April 24, 2025
    Report Date
    September 9, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    H11: SINCE NO LOT NUMBER IS AVAILABLE, A DETAILED INVESTIGATION, TESTS OR REFERENCE SAMPLES OR BATCH REVIEW CANNOT BE CONCLUDED. THEREFORE, THIS COMPLAINT WILL BE CLOSED, THIS ISSUE WILL BE MONITORED THROUGH PMS PRODUCT TRENDS AND MALFUNCTION. IF ANY TRENDS PICKED UP, THIS WOULD FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED LOT NUMBER, 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: REVISION 21 OF (B)(4) DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF (B)(4). COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002572, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002572 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGED IN THE MACHINE MULTIVAC 10 ON 03-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3G05378 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 AND MANUFACTURED IN THE MACHINE LS11, ON 01-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3G05412 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32 AND MANUFACTURED IN THE MACHINE LS24, ON 02-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3G05413 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 AND MANUFACTURED IN THE MACHINE LS25, ON 01-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3G05377 WAS MANUFACTURED ACCORDING TO THE WI VERSION 31 AND MANUFACTURED IN THE MACHINE LS25, ON 30-JUL-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3G05885 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32 AND MANUFACTURED IN THE MACHINE LS11, ON 02-AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3G04688 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 01- AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3G04689 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 02- AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3G05128 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 02- AUG-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3G02837 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 29- JUL-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 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA MULTIPLE DAILY INJECTION (MDI). THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN. NO FURTHER INFORMATION WAS 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
    2143517 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002833 6002572 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female