BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21157119 · Received January 15, 2025

    Report

    Report Number
    3003442380-2024-37090
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 9, 2024
    Report Date
    November 7, 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

    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. REVISION 21 OF RECORD (B)(4) DOES NOT REQUIRE A TYPE 2 REPORTABLE COMPLAINT TO INITIATE A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS CREATED AND SUBSEQUENTLY CLOSED TO DOCUMENT THE DEVICE HISTORY RECORD (DHR) REVIEW, WHICH WAS NECESSARY TO ADVANCE THE PARENT RECORD TO THE REVIEW AND SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6000576 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6000576 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 103 AND MANUFACTURED IN THE LINE 7 ON 22/APR/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3D01746 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC01, ON 19/APR/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3D01747 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC01, ON 21/APR/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DEVIATION WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE; NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. EXTENDED INSPECTION IS NOT RELATED WITH THE CLAIMED MALFUNCTION. 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 AN OCCLUSION DUE TO BLOCKAGE IN TUBING ON (B)(6) 2024 . THE BLOOD GLUCOSE OF THE PATIENT WAS HIGH WHICH WAS TREATED BY CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. NO FURTHER INFORMATION WAS 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
    1299745 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 6000576 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female