BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19686092 · Received July 7, 2024

    Report

    Report Number
    3003442380-2024-12622
    Event Type
    Malfunction
    Date Received
    July 7, 2024
    Date of Event
    May 26, 2024
    Report Date
    August 13, 2025
    Manufacturer
    UNOMEDICAL A/S
    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

    INITIAL AND FINAL MDR (B)(4) - MDR 3003442380-2024-12622 - DEVICE 2 OF 2.

    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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6010404 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND WI GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE). COMPLAINT INVESTIGATIONS: PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST AIR FLOW ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010404 WAS MANUFACTURED ACCORDING TO THE WI VERSION 82 MANUFACTURED IN THE MULTIVAC 08, ON 23/NOV/2024, WITH A TOTAL OF (B)(4) UNITS. ASSEMBLY: THE LOT 4L01886 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 22 NOV 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L1880 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 23 NOV 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L05415 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02 DEC 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L01881 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 24 NOV 2024, WITH A TOTAL OF (B)(4) UNITS THE LOT 4L05063 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 25 NOV 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03327 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 01 DEC 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03328 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 01 DEC 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04953 WAS ASSEMBLED ACCORDING TO WI VERSION 27 ON-LINE INSPECTION FOR ASSEMBLY OF QUICK SET ON 02 DEC 2024, WITH A TOTAL OF (B)(4) UNITS GLUING TUBING: THE LOT 4L01866 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET ON 29 OCT 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03186 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET ON 19 NOV 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04838 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET ON 01 DEC 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L04835 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET ON 28 NOV 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03189 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET ON 23 NOV 2024, WITH A TOTAL OF (B)(4) UNITS. THE LOT 4L03187 WAS ASSEMBLED ACCORDING TO WI VERSION 42 ON-LINE INSPECTION FOR AUTOMATIC GLUING OF QUICK SET ON 21 NOV 2024, 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 WERE IDENTIFIED; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE TUBING CONNECTOR DETACHED FROM INFUSION SET (CANNULA PART/BASE PIECE) AND LOT 6010404 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT AND MALFUNCTION CODE. 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 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 ON (B)(6) 2024 THE PATIENT EXPERIENCED ISSUE WITH TWO INFUSION SETS WERE FELL OFF DURING USE. THE AREA OF INSERTION WAS CLEANED AND AIR-DRIED. THE INFUSION SET WAS USED FOR TWO DAYS. THE BLOOD GLUCOSE LEVEL WAS 400 MG/DL ON (B)(6) 2024 AND 150 MG/DL ON (B)(6) 2024. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED 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
    931069 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 UNKNOWN 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female