BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 21663080 · Received March 21, 2025

    Report

    Report Number
    3003442380-2025-04295
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    February 14, 2025
    Report Date
    June 24, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244014541
    PMA / PMN Number
    K032854
    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: THE REFERENCE SAMPLES FOR THE LOT 6007796 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 05/MAR/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 2082583 COMPLAINT TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007796 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 115 MANUFACTURED IN THE LINE 9, ON 29/JUN/2024, WITH A TOTAL OF (B)(4) UNITS. TRENDING: A QUERY WAS RUN IN DATABASE ON 23/JUN/2025 AGAINST MALFUNCTION CODE EVALUATED OCCLUSION AT INFUSION SITE (E.G., OCCLUSION ALARM FROM THE INFUSION PUMP MAY HAVE SOUNDED) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6007796 AND NO OTHER 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, NO OTHER 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 CANADA. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2025. THE BLOCKAGE WAS AT THE SITE. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. 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
    800486 AUTOSOFT 90 INSET II 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL UM-D 1000281 6007796 05705244014541

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female