BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19819371 · Received July 24, 2024

    Report

    Report Number
    3003442380-2024-16154
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    June 15, 2024
    Report Date
    November 6, 2025
    Manufacturer
    UNOMEDICAL A/S
    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 COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003992, IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003992 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 AND MANUFACTURED IN THE LINE L5 ON 07-NOV-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 3L00038 WAS MANUFACTURED ACCORDING TO THE WI VERSION 10 AND MANUFACTURED IN THE MACHINE IGTL01, ON 03-NOV-2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING OF THE LOT 3L00039 WAS MANUFACTURED ACCORDING TO THE WI VERSION 10 AND MANUFACTURED IN THE MACHINE IGTL01, ON 05-NOV-2023, 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: 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 CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FACED A BLOCKAGE EVENT WITH AN INFUSION SET WHERE THE TUBING WAS BLOCKED AND WAS ALERTED BY ALARM 2 FOLLOWED BY ALARM 26. THIS LED TO INCREASE IN THE BLOOD GLUCOSE LEVEL AND THE PATIENT TOOK THE CORRECTION INJECTION VIA MULTIPLE DAILY INJECTIONS TO MANAGE THE SAME. ALSO, PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. 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
    102997 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6003992 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male