BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21110133 · Received January 9, 2025

    Report

    Report Number
    3003442380-2024-36486
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    December 6, 2024
    Report Date
    June 3, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(6). 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 TUBING DETACHED FROM TUBING-TUBING CONNECTOR. THE BATCH 6003741 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. FUNCTIONAL TEST (STATIC PULL TEST) ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, REFERENCE SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003741 WAS MANUFACTURED ACCORDING TO THE WI VERSION 108 MANUFACTURED IN THE LINE 8, ON 19/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 3K02764 WAS MANUFACTURED ACCORDING TO THE WI VERSION 56 MANUFACTURED IN THE MACHINE SC03, ON 16/OCT/2023 WITH A TOTAL OF (B)(4) UNITS. THE LOT 3K01475 WAS MANUFACTURED ACCORDING TO THE WI VERSION 56 MANUFACTURED IN THE MACHINE SC03, ON 17/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 WERE IDENTIFIED RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 03/JUN/2025 AGAINST MALFUNCTION CODE EVALUATED TUBING DETACHED FROM TUBING-TUBING CONNECTOR AND LOT 6003741 AND OTHER 1 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, OTHER 1 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) DEVICE 1 OF 3. 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 WILL FLAG ON THE TRIPS AND ALERTS ACCORDING TO THE OMQR PROCEDURE.

    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 THREE INFUSION SET TUBE DETACHMENT EVENT ON (B)(6) 2024. THE SITE OF DETACHMENT WAS FROM CONNECTOR. THE ONE INFUSION SET WAS IN USE FOR 1-12 HORS AND THE REST 2 IS FOR LESS. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT WAS TREATED WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352335 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 6003741 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female