BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 30

    MDR report key: 19571338 · Received June 19, 2024

    Report

    Report Number
    3003442380-2024-08998
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    May 6, 2024
    Report Date
    August 14, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018365
    PMA / PMN Number
    K061374
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1890609 - DEVICE 2 OF 4

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1890609: 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6004579 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 03 FOR THE CODE ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E. NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT). COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WI VERSION 03 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6004579 WAS MANUFACTURED ACCORDING TO THE WI VERSION 26 IN THE LINE 01, 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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE ADHESIVE PATCH DOES NOT ADHERE TO THE SKIN AT POINT OF APPLICATION (I.E. NOT STICKY, NO ATTACHMENT, OR A FEW MINUTES OF ATTACHMENT) AND LOT 6004579 AND OTHER ONE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6004579 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM, NO NON-CONFORMANCE RAISED DURING PRODUCTION, OTHER ONE 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 PLAN. 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. IT WAS REPORTED THAT PATIENT FACED 4 INFUSIONS SET FALL OFF EVENTS ON (B)(6) 2024. INFUSION SET FELL OFF DURING PHYSICAL ACTIVITY/SWEATING, SWIMMING, OR BATHING. AREA OF INSERTION WAS CLEANED, AIR DRIED AND FREE FROM HAIR. PATIENT WAS ASSISTED BY BULTER MEMORIAL HOSPITALS. PATIENT WAS EXPERIENCED WITH HIGH LEVEL OF KETONES AND IT LED TO BE LIFE THREATENING. 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
    2211189 AUTOSOFT 30 UNO INSET 30 60/13 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002825 6004579 05705244018365

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Life Threatening| R| H