BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 20803264 · Received November 27, 2024

    Report

    Report Number
    3003442380-2024-33051
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    October 18, 2024
    Report Date
    August 12, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    PMA / PMN Number
    K032854
    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 (B)(4)- DEVICE 9 OF 9

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 2053454: 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 FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE BATCH 6005955 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. THE REFERENCE SAMPLES FOR BATCH 6005955 WERE PREVIOUSLY TESTED IN COMPLAINT 2106650 ON 03/JUN/2025. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 6005955 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 111 IN THE LINE L-7, ON 11/MAR/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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 07/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6005955 AND OTHER 14 COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6005955 AND MALFUNCTION CODE. THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. THE PATIENT MOTHER REPORTED THAT THE PATIENT EXPERIENCED INFUSION SET CANNULA WAS BENT WITHIN 3 HOURS OF INSERTION AT THIGH AND ARM ON 18-OCT-2024, WHICH CAUSE THE PATIENT BLOOD GLUCOSE LEVELS WAS ELEVATED TO 527 MG/DL, THEREFORE PATIENT HAD CHANGED OUT THE INFUSION SET EVERY TIME. THE PATIENT MOTHER ALSO REPORTED THAT HER DAUGHTER HAD LARGE KETONES. THE PATIENT 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
    2470330 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6005955 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Required Intervention