BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 19759295 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-14861
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    June 10, 2024
    Report Date
    August 9, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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 SOFT CANNULA, INTRODUCER NEEDLE OR STEEL NEEDLE WAS FOUND ABNORMAL EITHER PRIOR TO USE, DURING USE OR UPON REMOVAL. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE. THE BATCH 6000682 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR BATCH 6000682 WERE PREVIOUSLY TESTED IN COMPLAINT (B)(4) ON 01/AUG/2025. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL LEAK TEST 2 ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6000682 WAS MANUFACTURED ACCORDING TO WI VERSION 104 IN THE LINE 08, ON 23/MAY/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 08/AUG/2025 AGAINST MALFUNCTION SOFT CANNULA, INTRODUCER NEEDLE OR STEEL NEEDLE WAS FOUND ABNORMAL EITHER PRIOR TO USE, DURING USE OR UPON REMOVAL. ONLY USE IF A SPECIFIC MALFUNCTION CANNOT BE DETERMINED AND NO DESCRIPTION ABOUT FAILURE TYPE AND LOT 6000682 AND ANOTHER ONE COMPLAINT HAS 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, NO NON-CONFORMANCE RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, TWO COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 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) (SISTER) . EVENT OCCURRED IN THE UNITED STATES, IT WAS REPORTED THAT ON 10-JUN-2024 THE PATIENT EXPERIENCED AN ISSUE BECAUSE ITS SUSPECTS CANNULA ISSUE. THE BLOOD GLUCOSE LEVEL WAS 800 MG/DL AND PATIENT WERE ADMITTED TO HOSPITAL AND GOT IV INSULIN BOLUS. THE PATIENT ALSO GOT DIAGNOSED WITH HIGH KETONE LEVEL IN BODY AND ITS SHOWING LIFE THREATENING AND DANGEROUS. 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
    2518879 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6000682 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention| H