BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21581240 · Received March 12, 2025

    Report

    Report Number
    3003442380-2025-03478
    Event Type
    Malfunction
    Date Received
    March 12, 2025
    Date of Event
    October 24, 2024
    Report Date
    June 28, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244021099
    PMA / PMN Number
    K032854
    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 6007963 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 30/JAN/2024. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK TEST. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE COMPLAINT (B)(4) TEST REPORT.PDF ATTACHED IN THIS RECORD. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6003731 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) 4902137 VERSION 108 MANUFACTURED IN THE LINE # L-5, LI50 ON 18/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 26/MAR/2025 AGAINST MALFUNCTION CODE OCCLUSION AT INFUSION SITE (E.G. OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6003731, WITH NO TREND IDENTIFIED. 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, NO TREND IDENTIFIED FOR 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 OCCURED IN THE UNITED STATES. ON (B)(6) 2024, THE PATIENT REPORTEDLY ENCOUNTERED A PROBLEM WITH THEIR INFUSION SET, SPECIFICALLY AN OBSTRUCTION IN THE INSULIN FLOW. THIS INCIDENT OCCURRED AT LEAST 3 HOURS AFTER THE SET WAS INSERTED. THE BLOCKAGE WAS PINPOINTED AT THE INSERTION SITE, WHICH WAS LOCATED IN THE PATIENT'S LOWER BACK AREA. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN 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
    1399348 AUTOSOFT XC UNO INSET I 80/6 GREY TCAP 10PACK US FPA UNOMEDICAL UM-D 1003912 6003731 05705244021099

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female