BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20244963 · Received September 18, 2024

    Report

    Report Number
    3003442380-2024-25796
    Event Type
    Malfunction
    Date Received
    September 18, 2024
    Date of Event
    August 10, 2024
    Report Date
    February 17, 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 THE REFERENCE SAMPLES FOR THE LOT 6004421 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE PR 1913985 ON 06/FEB/2025. REFERENCE SAMPLES WERE TESTED AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT TW PR (B)(4) COMPLAINT TEST REPORT. AND ADDITIONAL TESTS FOR THE REFERENCE SAMPLES WERE DOCUMENTED FOR THE MALFUNCTION CODE INSERTION WITHOUT REMOVING NEEDLE GUARD. VISUAL INSPECTION WAS FOUND WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6004421 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 108 MANUFACTURED IN THE LINE 7, ON 02/DEC/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 WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 14/FEB/2025 AGAINST MALFUNCTION CODE INSERTION WITHOUT REMOVING NEEDLE GUARD AND LOT 6004421 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6004421 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, HARM NO REPORTABLE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO OTHER COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. 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 UNITES STATES. IT WAS REPORTED THAT PATIENT FACED AN EVENT WHERE INTRODUCER NEEDLE WAS INSERTED WITHOUT REMOVING THE NEEDLE GUARD. THE EVENT OCCURRED ON (B)(6) 2024. PATIENT REPORTED THAT NEEDLE WAS NOT GOING PROPERLY IN THE BODY. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302096 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6004421 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male