BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT XC

    MDR report key: 20209529 · Received September 13, 2024

    Report

    Report Number
    3003442380-2024-24795
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    May 29, 2024
    Report Date
    September 19, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244026001
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-24795. 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 6003992 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND (WI) GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED). 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 (WI) VERSION 3 ON REFERENCE SAMPLES, 05 SAMPLES OUT 05 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO (WI) VERSION 2 ON REFERENCE SAMPLES, 05 SAMPLES OUT 05 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: THE LOT 6003992 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 108 MANUFACTURED IN THE INSET 2, ON 07/NOV/2023, 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; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 05/AUG/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6003992 AND NO OTHER COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003992 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, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONE 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 THE PATIENT WAS HOSPITALIZED DUE TO LEAKAGE AT SITE EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE BLOOD GLUCOSE LEVEL WAS FOUND TO BE 590MG/DL. THE PATIENT WAS TREATED WITH BOLUS VIA PUMP, 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
    1563173 AUTOSOFT XC INSET I 2-PACK 60/6 GREY TCAP FPA UNOMEDICAL A/S 1010900 6003992 05705244026001

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Hospitalization| R