BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 22085515 · Received May 27, 2025

    Report

    Report Number
    3003442380-2025-09904
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 11, 2025
    Report Date
    September 1, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244018488
    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 21 OF 3709030 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 3709030. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD 2282724. THE BATCH 6011618, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011618 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 100 AND PACKAGING IN THE MULTIVAC 14 ON 12/FEB/2025, WITH A TOTAL OF (B)(4)UNITS. THE SUB-ASSEMBLY, WELDING LOT 5A04054 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 AND MANUFACTURED ON MACHINES LS24 & LS25, ON 26/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5B00024 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 AND MANUFACTURED ON MACHINES LS24 & LS25, ON 11/FEB/2025, WITH A TOTAL OF (B)(4)UNITS. LOT 5A04035 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 AND MANUFACTURED ON MACHINES LS06 & LS07, ON 11/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5B03014 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 AND MANUFACTURED ON MACHINES LS24 & LS25, ON 17/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5A04028 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 34 AND MANUFACTURED ON MACHINES LS06 & LS07, ON 24/JAN/2025, WITH A TOTAL OF (B)(4)UNITS. THE SUB-ASSEMBLY, GLUING OF CONNECTOR LOT 5A04002 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 AND MANUFACTURED ON LINE 3, ON 25/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5B00041 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 AND MANUFACTURED ON LINE 3, ON 10/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5B00046 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 AND MANUFACTURED ON LINE 3, ON 16/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 5B02913 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 AND MANUFACTURED ON LINE 3, ON 19/FEB/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 4J02557 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 AND MANUFACTURED ON LINE 3, ON 24/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. LOT 4M03225 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 37 AND MANUFACTURED ON LINE 3, ON 24/JAN/2025, 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. 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 THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON 11-MAY-2025.THE BLOCKAGE WAS AT THE SITE. THE BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714790 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL UM-D 1002835 6011618 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female