BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 30

    MDR report key: 22216956 · Received June 17, 2025

    Report

    Report Number
    3003442380-2025-10714
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    May 14, 2025
    Report Date
    September 5, 2025
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    05705244018396
    PMA / PMN Number
    K061374
    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 3003442380-2025-10714. 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 - REVISION 21 OF 3709030 DOES NOT REQUIRE A COMPLAINT THAT IS TYPE 2 REPORTABLE TO OPEN A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS OPENED AGAINST A PREVIOUS REVISION OF 3709030. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6011114 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6011114 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 29 AND MANUFACTURED IN THE LINE 1 ON 14/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. THE SUB-ASSEMBLY, GLUING OF TUBING OF THE LOT 5A01363 WAS MANUFACTURED ACCORDING TO THE WI VERSION 66 AND MANUFACTURED IN THE MACHINE SC07, ON 10/JAN/2025, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DHR SHOWED THAT DURING THE FINAL OUTGOING INSPECTION THE TEST 6 ONE SAMPLE WAS FOUND WITH MISSING GLUE ON TUBING CONNECTOR. ACCORDING TO THE EXTENDED SAMPLING HAS BEEN ACCEPTED. HOWEVER, 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: AN EXTENDED RELATED TO THE REPORTED MALFUNCTION WAS RAISED DURING THE PROCESS, THEREFORE, FURTHER ACTIONS ARE REQUIRED. THIS COMPLAINT REQUIRES FURTHER CORRECTIVE AND PREVENTIVE ACTION (CAPA) DETERMINATION ASSESSMENT.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4) - DEVICE 2 OF 3.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SETS TUBING DETACHED EVENTS ON (B)(6) 2025 FROM CONNECTOR. PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957140 AUTOSOFT 30 UNO INSET 30 110/13 GREY TCAP 10PK INT FPA UNOMEDICAL DEVICES S.A. DE C.V. 1002826 6011114 05705244018396

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female