BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19759345 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-14617
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    May 1, 2024
    Report Date
    February 5, 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

    INITIAL AND FINAL MDR - 1913839 - MDR 3003442380-2024-14617- DEVICE 4 OF 10.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-14617. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 REFERENCE SAMPLES FOR THE LOT 6003524 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE PR (B)(4) ON 29/JAN/2025. THE REFERENCE SAMPLES WERE TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT. AND ADDITIONAL TESTS FOR THE REFERENCE SAMPLES WERE DOCUMENTED FOR THE MALFUNCTION ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE), REFER TO ADHESIVE PATCH ANOMALY. (ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE, UNDER SECTION 06.14. AND THE VISUAL INSPECTION WAS FOUND WITHIN SPECIFICATIONS.) DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003524 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 MANUFACTURED IN THE LINE 3, ON 08/OCT/2023, WITH A TOTAL OF (B)(4) UNITS. NON-CONFORMANCE (NC) (B)(4) DISCREPANCY BETWEEN THE INSTRUCTIONS FOR USE (IFU) IMPLEMENTED VS THE INITIAL SCOPE AND IMPACT ASSESSMENT OF THE CHANGE CONTROL REQUEST (CCR) FOR AUTOSOFT XC AND WOMBAT. NOT RELATED TO THE MALFUNCTION REPORTED ON THIS COMPLAINT. THE REVIEW OF THE DHR SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESSES HAD BEEN FULFILLED AND MET THE REQUIREMENTS, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 04/FEB/2025 AGAINST MALFUNCTION ADHESIVE PATCH LIFTS OR DETACHES DURING USE (ONLY USE FOR CONFIRMED ADHESIVE ISSUE) AND LOT 6003524 AND ANOTHER 1 COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003524 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO HARM REPORTED, NO DEFECT ON TESTS RETURNED SAMPLES, ANOTHER 1 COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED, NC RAISED NOT RELATED TO THIS COMPLAINT. 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. ON (B)(6) 2024, PATIENT REPORTED THAT 10 INFUSION SETS FELL OFF WITHIN 2 DAYS OF USE. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    718518 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6003524 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male