BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 20299012 · Received September 25, 2024

    Report

    Report Number
    3003442380-2024-24608
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    August 24, 2024
    Report Date
    August 7, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    K032854
    Adverse Event
    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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED. THE BATCH 6002824 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATION: THE REFERENCE SAMPLES CANNOT BE TESTED BECAUSE THERE WAS NO SPECIFIC MALFUNCTION TO INVESTIGATE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002824 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106, MANUFACTURED IN THE LINE INSET 7, ON 21/AUG/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 06/AUG/2025 AGAINST MALFUNCTION CODE MALFUNCTION CANNOT BE DETERMINED, HARM CODE UNTREATED DIABETIC KETOACIDOSIS OR ISOLATED ELEVATED BLOOD GLUCOSE WHICH THE PATIENT IS UNABLE TO SELF-MANAGE REQUIRING INTERVENTION BY AN HEALTH CARE PROFESSIONAL (HCP) OR REQUIRES EMERGENCY ADVANCED LIFE SUPPORT TO PREVENT PERMANENT ORGAN DAMAGE AND LOT 6002824 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT NUMBER, HARM CODE AND MALFUNCTION CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO 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 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. IT WAS REPORTED THAT, THE PATIENT EXPERIENCED AN OCCLUSION ALARM, INDICATING A BLOCKAGE IN THE INSULIN DELIVERY SYSTEM. THE OCCLUSION WAS LIKELY AT THE INFUSION SITE, WHICH WAS INSERTED IN THE THIGH USING A SOFT CANNULA INFUSION SET. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2024 DUE TO A DIABETES-RELATED ISSUE, WITH THE HIGHEST BLOOD GLUCOSE (BG) READING OF 448 MG/DL AND HIGH KETONES PRESENT. THE SUSPECTED CAUSE OF THE OCCLUSION WAS UNKNOWN. THE PATIENT RECEIVED INTRAVENOUS (IV) FLUIDS CONSISTING OF SALINE AND INSULIN AS TREATMENT, WHICH RESOLVED THE ISSUE. A PUMP SYSTEM CHECK CONFIRMED THE OCCLUSION ALARM. THE PATIENT HAD BEEN USING THE INSULIN PUMP FOR 2-3 DAYS, ALONG WITH THE SAME CARTRIDGE AND INFUSION SET. NO PERMANENT DAMAGE WAS IDENTIFIED BY THE HEALTHCARE PROVIDER. AT THE TIME OF THE REPORT, THE PATIENT HAD NOT YET BEEN RELEASED FROM THE HOSPITAL. 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
    2248692 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6002824 05705244018181

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female Hospitalization| R