BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20850698 · Received December 5, 2024

    Report

    Report Number
    3003442380-2024-33649
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 7, 2024
    Report Date
    October 30, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018303
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL (B)(4) - DEVICE 4 OF 8.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-33649. 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 RECORD (B)(4) DOES NOT REQUIRE A TYPE 2 REPORTABLE COMPLAINT TO INITIATE A CHILD INVESTIGATION. THIS CHILD INVESTIGATION WAS CREATED AND SUBSEQUENTLY CLOSED TO DOCUMENT THE DHR REVIEW, WHICH WAS NECESSARY TO ADVANCE THE PARENT RECORD TO THE REVIEW AND SUMMARY. COMPLAINT INVESTIGATION RESULTS: A COMPLAINT INVESTIGATION HAS BEEN INITIATED UNDER COMPLAINT INVESTIGATION CHILD RECORD (B)(4). THE BATCH 6002505 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6002505 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 AND MANUFACTURED IN THE LINE 6 ON 28/JUL/2023, WITH A TOTAL OF (B)(4) UNITS. THE REVIEW OF THE DHR REVEALED THAT DURING OUTGOING TEST 6, ONE SAMPLE WAS FOUND WITH THE RELEASE LINER DELAMINATES FROM ADHESIVE PATCH. CONSEQUENTLY, AN EXTENDED FOR DELAMINATION WAS RAISED. HOWEVER, ACCORDING TO THE SAMPLING RESULTS, THE LOT WAS ACCEPTED. FURTHERMORE, THE OVERALL REVIEW OF THE DHR CONFIRMS THAT ALL REQUIRED PROCESS-RELATED TESTS WERE COMPLETED AND MET THE APPLICABLE REQUIREMENTS. NO DEVIATIONS WERE IDENTIFIED, AND NO MAINTENANCE EVENTS WERE RECORDED IN RELATION TO THE COMPLAINT CODE. CONCLUSION SUMMARY OF COMPLAINT INVESTIGATION: AS A RESULT OF THE FOLLOWING: NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION RELATED TO COMPLAINT MALFUNCTION CODE, THEREFORE, 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.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM IT WAS REPORTED THAT PATIENT FACED EIGHT INFUSION SET CANNULA LEAKAGE EVENT. THE LEAKAGE WAS IN THE CANNULA. THE INFUSION SET WAS IN USE FOR 36-48 HOURS. THE INSERTION SITE WAS ABDOMEN.THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS 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
    314910 AUTOSOFT 90 UNO INSET II 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL A/S 1002823 6002505 05705244018303

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown