BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19591599 · Received June 23, 2024

    Report

    Report Number
    3003442380-2024-09982
    Event Type
    Malfunction
    Date Received
    June 23, 2024
    Date of Event
    May 9, 2024
    Report Date
    February 6, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018242
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4)- MDR 3003442380-2024-09982- DEVICE 2 OF 2.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2024-09982. CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED COMMON DEVICE NAME UNDER D2, MODEL NUMBER, SERIAL NUMBER, PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER, EXPIRATION DATE UNDER D4 AND MANUFACTURING DATE UNDER H4. 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 REFERENCE SAMPLES FOR THE LOT 6003331 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE PR (B)(4) ON 30/JAN/2025. TEST RESULTS: AND ADDITIONAL TESTS FOR THE REFERENCE SAMPLES WERE DOCUMENTED FOR THE MALFUNCTION LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED), UNDER SECTION 06.15 FOR VISUAL/6.1 FOR FLOW/6.2 FOR LEAK. ALL RESULTS WERE FOUND WITHIN SPECIFICATIONS AS PER THE TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6003331 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 107 MANUFACTURED IN THE LINE 6, ON 24/SEP/2023, 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 WERE IDENTIFIED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 05/FEB/2025 AGAINST MALFUNCTION CODE LEAKAGE FROM INFUSION SITE (CANNULA BASE PART/CANNULA) (SPECIFIC CAUSE NOT IDENTIFIED) AND LOT 6003331 AND ANOTHER 1 COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6003331 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR REFERENCE SAMPLES, NO HARM REPORTED, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, OTHER 1 COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET SURVEILLANCE ACTIVITIES.

    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 SET LEAKAGE AT THE SITE EVENT ON . INFUSION SET HAS BEEN USED FOR 3 MINUTES. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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
    1068329 AUTOSOFT 90 UNO INSET II 60/6 PINK TCAP 10PK INT FPA UNOMEDICAL A/S 1002821 6003331 05705244018242

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female