BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 19729498 · Received July 12, 2024

    Report

    Report Number
    3003442380-2024-14066
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    May 28, 2024
    Report Date
    November 7, 2025
    Manufacturer
    UNOMEDICAL A/S
    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 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: PER 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 6003836, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003836 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 94 AND PACKAGED IN THE MACHINE MULTIVAC 10 ON 16-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. WELDING: THE SUB-ASSEMBLY, WELDING OF THE LOT 3K02305 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32 AND MANUFACTURED IN THE MACHINE LS24-LS25-LS11, ON 13-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, WELDING OF THE LOT 3K02298 WAS MANUFACTURED ACCORDING TO THE WI VERSION 32 AND MANUFACTURED IN THE MACHINE LS24-LS25-LS11, ON 13-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. GLUING CONNECTOR: THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3K02287 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 12-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3K02288 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 13-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3K02289 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 14-OCT-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING CONNECTOR OF THE LOT 3K02294 WAS MANUFACTURED ACCORDING TO THE WI VERSION 35 AND MANUFACTURED IN THE MACHINE GLUING 3, ON 15-OCT-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 THE RELATED EVENT: 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

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET OCCLUSION AT SITE EVENTS ON (B)(6) 2024 AFTER 3 OR MORE HOURS INSERTION. INFUSION SET HAS NOT BEEN MORE THAN 48 HOURS. THE BLOOD GLUCOSE LEVEL WAS 183MG/DL. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390325 TRUSTEEL UNO CONTACT DETACH G29 60/8TCAP 10PK INT FPA UNOMEDICAL A/S 1002835 6003836 05705244018488

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female