BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19826802 · Received July 25, 2024

    Report

    Report Number
    3003442380-2024-16755
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    May 29, 2024
    Report Date
    November 26, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026032
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 -(B)(4) MDR 3003442380-2025-16755. THE INITIAL MDR WITH MANUFACTURING REPORT NUMBER (3003442380-2025-16755), WAS SUBMITTED ON 19-NOV-2025. UPON RECEIVING ADDITIONAL INFORMATION FROM MANUFACTURER ON 24-NOV-2025, IT WAS DISCOVERED THAT THE MALFUNCTION CODE EARLIER REPORTED TUBING DETACHED FROM HUB HAS BEEN NOW CHANGED TO LEAKAGE FROM TUBING OR THE INTERFACE BETWEEN THE TUBING AND THE CONNECTORS. UPON COMPLETION OF THE INVESTIGATION, THE MANUFACTURING DATE WAS UPDATED AS 22-MAY-2025. ADDITIONAL INFORMATION - THIS MDR IS BEING SUBMITTED TO INCLUDE THE BELOW: B5: DESCRIBE EVENT OR PROBLEM H6: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS H11: INVESTIGATION SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED TO REVIEW THE DEVICE HISTORY RECORD (DHR) ASSOCIATED WITH THE REPORTED ISSUE. THE BATCH 6013376 , IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6013376 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 123 IN THE L185 ON 22/MAY/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY: GLUING OF TUBING THE LOT 5E00712 WAS MANUFACTURED ACCORDING TO THE FORM-001865 VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 17-MAY-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5D03618 WAS MANUFACTURED ACCORDING TO THE FORM- 001865 VERSION 3 AND MANUFACTURED IN THE MACHINE ITL03, ON 23-APR-2025, WITH A TOTAL OF (B)(4) UNITS. THE LOT 5E00711 WAS MANUFACTURED ACCORDING TO THE FORM- 001865 VERSION 3 AND MANUFACTURED IN THE 03,, ON 13-MAY-2025 , 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 WAS IDENTIFIED, NOR MAINTENANCE EVENTS WERE RECORDED RELATED TO COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT CODE, NO TREND IDENTIFIED FOR 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 (CAPA) PLAN. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 1 OF 2

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET LEAKAGE EVENT ON (B)(6) 2025. THE SET WAS IN USE FOR 6 HOURS OR 7 HOURS. THE LEAKAGE WAS AT T: LOCK. THE BLOOD GLUCOSE LEVEL WAS 600 MG/DL AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP FOR (B)(6) 2025 AND THEN AN INJECTION FOR (B)(6) 2025 AND MANUAL INJECTION FOR (B)(6) 2025. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 2 INFUSION SETS CANNULA KINKED EVENTS ON 29-MAY-2024 AND THE INFUSION SETS SEEMED A LITTLE MISALIGNED FROM TUBING TO CANNULA, AND CAUSED PAIN WHEN INSERTING. THE PATIENT NOTICED SYMPTOMS THREE OR MORE HOURS AFTER INSERTION. THE INFUSION SETS HAS BEEN USED FOR SIX HOURS. INSERTION SITE WAS THIGH. PATIENT REGULARLY ROTATE SITE LOCATION. FURTHERMORE, PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE BLOOD GLUCOSE LEVEL WAS 360 MG/DL AT THE TIME OF EVENTS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL 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 WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374287 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 1010899 6003985 05705244026032

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female