BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 20936566 · Received December 16, 2024

    Report

    Report Number
    3003442380-2024-22492
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    October 14, 2024
    Report Date
    February 18, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    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)- DEVICE 2 OF 6

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2024-22492. 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 6007373 HAVE ALREADY BEEN PREVIOUSLY TESTED. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR AIR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT TW PR. 2062013 COMPLAINT TEST REPORT.PDF ATTACHED IN THIS RECORD. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6007373 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 114 MANUFACTURED IN THE LINE 8, ON 03/JUN/2024, 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 DATA BASE ON 21/JAN/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6007373 AND ANOTHER 22 COMPLAINTS HAVE BEEN REGISTERED IN DATA BASE FOR THE SAME LOT 6007373 AND MALFUNCTION CODE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4) EVENT OCCURRED IN SPAIN IT WAS REPORTED THAT THE PATIENT FACED SIX INFUSION SETS CANNULA KINKED EVENTS ON (B)(6)2024, (B)(6)2024, (B)(6)2024, (B)(6)2024,(B)(6)2024, AND (B)(6)2024. EVENTS WERE OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT ABDOMEN. PATIENT REPLACED THE INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. COMPANY 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.

    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
    2444476 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6007373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown