BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19988848 · Received August 15, 2024

    Report

    Report Number
    3003442380-2024-21146
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 10, 2024
    Report Date
    November 27, 2025
    Manufacturer
    UNOMEDICAL A/S
    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 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 6003275 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003275 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE 8 ON 24/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3J01470 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC09, ON 17/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 3J01471 WAS MANUFACTURED ACCORDING TO THE WI VERSION 55 AND MANUFACTURED IN THE MACHINE SC09, ON 19/SEP/2023, WITH A TOTAL OF (B)(4) UNITS. THE DHR REVIEW INDICATED THAT DURING OUTGOING TEST 6, ONE SAMPLE WAS FOUND TO HAVE CONTAMINATION. AN EXTENDED SAMPLING WAS ALSO CONDUCTED, AND THE RESULTS WERE ACCEPTED. THEREFORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: THE DHR REVIEW IDENTIFIED MINOR FINDINGS. THEY WERE MANAGED ACCORDING TO PROCEDURE AND DID NOT IMPACT COMPLIANCE. NO NON-CONFORMITIES (NC) WERE RECORDED IN CONNECTION WITH THE MALFUNCTION CODE REPORTED IN THE COMPLAINT. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION NOR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    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. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF OCCLUSION ALARM AT INFUSION SITE ON 10-JUL-2024. PATIENT REPORTED THAT BLOCKAGE WAS IN THE TUBING. PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434171 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003275 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female