BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUSTEEL

    MDR report key: 20911427 · Received December 12, 2024

    Report

    Report Number
    3003442380-2024-34211
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 8, 2024
    Report Date
    June 3, 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
    OTHER
    Health Professional
    N

    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 REFERENCE SAMPLES FOR THE LOT 6007784 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2083591 ON 25/MAY/2025. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR STATIC PULL OF THE TUBING-TUBING CONNECTOR. THE TEST RESULT WAS WITHIN SPECIFICATIONS. VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL STATIC PULL OF THE TUBING-TUBING CONNECTOR TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007784 WAS MANUFACTURED ACCORDING TO THE WI VERSION 97 MANUFACTURED IN THE LINE M14, ON 21/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. TUBE WITH BAND THE LOT 4F01600 WAS MANUFACTURED ACCORDING TO THE WI VERSION 64 MANUFACTURED IN THE LINE SC06 - SC05, ON 19/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4F01601 WAS MANUFACTURED ACCORDING TO THE WI VERSION 64 MANUFACTURED IN THE LINE SC08, ON 18/JUN/2024, 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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 03/JUN/2025 AGAINST MALFUNCTION CODE TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6007784 AND ANOTHER ONE COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6007784 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, COMPLAINT CONFIRMED AS FAILURE OF THE DEVICE, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFUSION SET TUBING DETACHMENT EVENT ON (B)(6) 2024. TUBING WAS DETACHED FROM CONNECTOR. THE SET WAS IN USE FOR EIGHT HOURS. BLOOD GLUCOSE LEVELS WERE REPORTED TO BE HIGH DURING THE EVENT. PATIENT TOOK BOLUS AND MULTI DAILY INJECTIONS TO ADDRESS THE EVENT, 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
    2146976 TRUSTEEL UNO CONTACT DETACH G29 60/6TCAP 10PK INT FPA UNOMEDICAL A/S 1002833 6007784 05705244018426

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female