BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 23287167 · Received October 15, 2025

    Report

    Report Number
    3003442380-2025-14727
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 8, 2025
    Report Date
    December 23, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244022386
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-14727), WAS SUBMITTED ON 15-OCT-2025. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 30-MAR-2025. 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 - COMPLAINT INVESTIGATION RESULTS: ELECTRONIC QUALITY MANAGEMENT SYSTEM (EQMS) SEARCH A QUERY WAS RUN IN THE EQMS ON 22-DEC-2025 AGAINST "LOT NUMBER 6012622 AND SIMILAR MALFUNCTION CODE ISSUES WITH THE TUBING EITHER PRIOR TO USE, DURING USE OR UPON REMOVAL. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE, THE REVIEW CONFIRMED THAT LOT 6012622 AND THE IDENTIFIED FAILURE MODE ARE NOT ASSOCIATED WITH ANY NCRS OR CORRECTIVE AND PREVENTIVE ACTION (CAPA)S OF THE SAME OR SIMILAR NATURE. SIMILAR COMPLAINTS SEARCH A QUERY WAS RUN IN THE EQMS ON 22-DEC-2025 AGAINST "LOT NUMBER" CRITERIA EQUAL 6012622 AND SIMILAR MALFUNCTION CODES ISSUES WITH THE TUBING EITHER PRIOR TO USE, DURING USE OR UPON REMOVAL. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE. THE COUNT OF COMPLAINT IS 1. THE COMPLAINT NUMBER IS (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW THE LOT 6012622 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 74 AND MANUFACTURED IN THE LINE INSET 8 ON 30-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. GLUE- TUBING LOT: THE LOT 5C04372 WAS MANUFACTURED ACCORDING TO THE WI VERSION 74 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 30-MAR-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D00123 WAS MANUFACTURED ACCORDING TO THE WI VERSION 74 AND MANUFACTURED IN THE MACHINE MULTIVAC 12 ON 01-APR-2025, 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. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED IN ACCORDANCE WITH APPLICABLE PROCEDURES. ALL REQUIRED IN-PROCESS AND FINAL TESTS WERE COMPLETED AND MET SPECIFIED REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED THAT RELATE TO THE COMPLAINT CODE. CONCLUSION: DHR REVIEW SUPPORTS COMPLIANCE WITH MANUFACTURING AND QUALITY REQUIREMENTS; NO ISSUES NOTED. VISUAL EVIDENCE REVIEW: NO PHOTO WAS PROVIDED TO SUPPORT VISUAL CONFIRMATION OF THE REPORTED ISSUE. CONCLUSION: UNABLE TO PERFORM VISUAL VERIFICATION; ASSESSMENT BASED ON AVAILABLE DOCUMENTATION ONLY. CAPA DETERMINATION ASSESSMENT - CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: BASED ON THE INVESTIGATION, NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH TRACKING AND TRENDING PER WI (MONTHLY TRIPS AND ALERTS). CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EQMS QUERIES, SIMILAR COMPLAINT SEARCHES, DEVICE HISTORY RECORD REVIEW, VISUAL EVIDENCE ASSESSMENT, AND CAPA DETERMINATION. NO NCRS OR CAPAS OF THE SAME OR SIMILAR NATURE WERE FOUND FOR LOT 6012622 AND RELATED MALFUNCTION CODES FOR TUBING ISSUES. ONE COMPLAINT WAS IDENTIFIED FOR THIS LOT, BUT NO TREND OR SYSTEMIC ISSUE WAS DETECTED. THE MANUFACTURING RECORDS CONFIRMED THAT THE LOT WAS PRODUCED IN COMPLIANCE WITH ALL REQUIREMENTS, WITH NO DEVIATIONS OR MAINTENANCE EVENTS NOTED. NO PHOTO EVIDENCE WAS PROVIDED, SO THE ASSESSMENT WAS BASED ON DOCUMENTATION ONLY. BASED ON THESE RESULTS, NO MANUFACTURING OR QUALITY ISSUES WERE IDENTIFIED, AND NO FURTHER INVESTIGATION IS REQUIRED. THE RECORD WILL BE CLOSED AND MONITORED THROUGH ROUTINE TRACKING AND TRENDING.

    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. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2025, WHERE THEY STAYED FOR 2 HOURS. THE VISIT WAS RELATED TO HIGH KETONE LEVELS, WHICH APPEARED TO BE CAUSED BY ISSUES WITH THE INFUSION SET TUBING. TO ADDRESS THEIR BLOOD GLUCOSE ISSUE, THE PATIENT ADMINISTERED MEDICATION VIA MULTIPLE DAILY INJECTIONS (MDI). THE PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM ON THE SAME DAY. NO FURTHER INFORMATION AVAILABLE WENT TO THE EMERGENCY ROOM (ER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185146 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1006922 6012622 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Required Intervention