BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 22058613 · Received May 21, 2025

    Report

    Report Number
    3003442380-2025-09273
    Event Type
    Injury
    Date Received
    May 21, 2025
    Date of Event
    April 15, 2025
    Report Date
    July 15, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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

    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 6010225 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. THE REFERENCE SAMPLES FOR THE LOT 6010225 HAVE ALREADY BEEN PREVIOUSLY TESTED FOR VISUAL INSPECTION AND TESTED FOR FLOW IN THE DATABASE 2228527 ON 02/JUL/2025. ALL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE (B)(4) TEST REPORT PDF ATTACHED IN THIS RECORD. 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 WORK INSTRUCTION (WI) VERSION 3 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. FUNCTIONAL AIR FLOW TEST ACCORDING TO WI VERSION 2 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6010225 WAS PACKAGING ACCORDING TO THE WI VERSION 120, IN THE LINE INSET 10, ON 14/NOV/2024, WITH A TOTAL OF (B)(4)UNITS. REVIEW OF THE DEVICE HISTORY RECORD (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 15/JUL/2025 AGAINST MALFUNCTION SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6010225 AND ONE OTHER COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6010225 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO SOFT CANNULA ISSUES, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, 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 PATIENT EXPERIENCED AN EVENT OF INFUSION SET BENT CANNULA WHICH LED TO HIGH BLOOD GLUCOSE ON (B)(6) 2025. THE EVENT OCCURRED IN THREE OR MORE HOURS AFTER INSERTION. THE INFUSION SET WAS IN USE FOR TWO DAYS. THE BLOOD GLUCOSE LEVEL WAS HIGH AND THE PATIENT TREAT IT WITH CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION. THE PATIENT'S MOTHER CALLED HEALTH CARE PROFESSIONAL FOR ASSISTANCE AS PATIENT WAS HAVING VOMITING AND STOMACHE. THE TRACE KETONES WERE ALSO PRESENT. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    937005 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1001680 6010225 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male