BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFTÂ XC

    MDR report key: 20341675 · Received October 1, 2024

    Report

    Report Number
    3003442380-2024-25455
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    August 18, 2024
    Report Date
    August 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 2001392 - MDR 3003442380-2024-25455 - DEVICE 1 OF 3.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2001392: CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED 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 6006449 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE COMPLAINT (B)(4) ON 01/NOV/2024. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. ALL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE 1950618 DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005749 WAS MANUFACTURED ACCORDING TO THE DOCUMENT 4905072 VERSION 114, AND MANUFACTURED IN THE LINE 3, ON 10/MAY/2024, 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 12/AUG/2025 AGAINST MALFUNCTION CODE INTRODUCER NEEDLE IS FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6006449 AND NO OTHER COMPLAINT HAVE 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 RELATED TO THE COMPLAINT, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO OTHER COMPLAINT RECEIVED ON 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, REPORTED THAT PATIENT FACED 3 INFUSION SETS BENT NEEDLE AFTER INSERTION. THE BLOOD GLUCOSE LEVEL WAS 503 MG/DL. HIGH BLOOD GLUCOSE WAS TREATED WITH CORRECTION INJECTION MULTIPLE DAILY INJECTION. PATIENT HAVING KETONES. KETONE LEVEL WAS DANGEROUS AND LIFE THREATENING. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES 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
    34502 AUTOSOFTÂ XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6006449 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention| L