BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20357878 · Received October 3, 2024

    Report

    Report Number
    3003442380-2024-28288
    Event Type
    Malfunction
    Date Received
    October 3, 2024
    Date of Event
    September 5, 2024
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    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: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6003940 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003940 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 AND MANUFACTURED IN THE LINE # 7 ON 29/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. THE DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT DURING OUTGOING TEST 4(B), ONE SAMPLE WAS FOUND WITH THE NEEDLE GUARD LIFTED. AN EXTENDED SAMPLING WAS PERFORMED AND ACCEPTED IN ACCORDANCE WITH ESTABLISHED PROCEDURES. ADDITIONALLY, DURING TEST #6, ONE SAMPLE WAS IDENTIFIED WITH A BLURRY 10X LABEL. CONSEQUENTLY, AN EXTENDED SAMPLING WAS ALSO CONDUCTED, AND THE RESULTS WERE ACCEPTED. THEREFORE, THE OVERALL REVIEW OF THE DEVICE HISTORY RECORD (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: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONE OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION, HARM CODE AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT WILL NOT REQUIRE FURTHER ROOT CAUSE INVESTIGATION OR CORRECTIVE AND PREVENTIVE ACTION (CAPA) PLAN. THEREFORE, 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 INFUSION FLOW BLOCKAGE AT SITE EVENT ON (B)(6)2024 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION WAS UPPER BUTTOCKS. THE BLOOD GLUCOSE LEVEL WAS FOUND TO BE HIGH AND PATIENT TOOK COORECTION BOLUS VIA PUMP. NO FURTHER INFORMATION AVAILABLE .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360987 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6003940 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male