BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUSTEEL

    MDR report key: 20037653 · Received August 22, 2024

    Report

    Report Number
    3003442380-2024-21917
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    May 2, 2024
    Report Date
    August 13, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018488
    PMA / PMN Number
    K041545
    Adverse Event
    Yes
    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: THE INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED. THE BATCH 6000890 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED THE REFERENCE SAMPLES FOR BATCH 6000890 WERE PREVIOUSLY TESTED IN (B)(4) ON 15/AUG/2024. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING: LOT 6000890 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 91 AND PACKAGING IN THE MULTIVAC 10, ON 14/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. WELDING: LOT 3E01930 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 30, WELDING IN THE MACHINE LS11, ON 10/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01931 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 30, WELDING IN THE MACHINE LS06, ON 12/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01932 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 30, WELDING IN THE MACHINE LS07, ON 12/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF CONNECTOR: LOT 3E00997 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35, GLUING OF CONNECTOR IN THE LINE L-3, ON 06/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01116 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35, GLUING OF CONNECTOR IN THE LINE L-3, ON 10/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01117 WAS MANUFACTURED ACCORDING TO THE WI) VERSION 35, GLUING OF CONNECTOR IN THE LINE L-3, ON 11/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01888 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 35, GLUING OF CONNECTOR IN THE LINE L-3, ON 12/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. GLUING OF TUBING: LOT 3E01925 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 55, GLUING OF TUBING IN THE MACHINE SC05, ON 11/MAY/2023, WITH A TOTAL OF (B)(4) UNITS. LOT 3E01926 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 55, GLUING OF TUBING IN THE MACHINE SPOT 06, ON 12/MAY/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 04/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED AND LOT 6000890 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6000890 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION 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 PATIENT FACED AN EVENT OF HIGH BLOOD GLUCOSE LEVEL ON 02-MAY-2024. PATIENT FIRST VISITED TO EMERGENCY ROOM AND LATER WAS ADMITTED TO HOSPITAL. BLOOD GLUCOSE LEVEL WAS 300-350 MG/DL AT THE TIME OF THE EVENT. PATIENT WAS FOUND TO BE KETONES. PATIENT TOOK IV AND FLUIDS OF SALINE AND INSULIN FOR THE TREATMENT. 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
    952612 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 6000890 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female