BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 22121781 · Received June 2, 2025

    Report

    Report Number
    3003442380-2025-10206
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 18, 2025
    Report Date
    June 25, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    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 REFERENCE SAMPLES FOR THE LOT 6010222 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2232531 ON 21/JUN/2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE 2232531 COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010222 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 120, MANUFACTURED IN THE LINE INSET 8, ON 22/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. GLUE TUBING DHR REVIEW: THE LOT 4L01412 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 2, MANUFACTURED IN THE MACHINE ITL03, ON 21/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. THE LOT 4K05984 WAS MANUFACTURED ACCORDING TO THE FORM VERSION 2, MANUFACTURED IN THE MACHINE ITL03, ON 09/NOV/2024 WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 24/JUN/2025 AGAINST MALFUNCTION CODE EVALUATED OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) AND LOT 6010222 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 RELATED TO THE COMPLAINT, 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 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 THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT (B)(6) 2025. THE BLOCKAGE WAS INT THE TUBING. THE PATIENT REPLACED THE 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
    642634 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001681 6010222 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female