BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 19554977 · Received June 17, 2024

    Report

    Report Number
    3003442380-2024-08743
    Event Type
    Injury
    Date Received
    June 17, 2024
    Date of Event
    April 20, 2024
    Report Date
    August 16, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018181
    PMA / PMN Number
    K032854
    Adverse Event
    Yes
    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 - DEVICE 8 OF 24

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR 1890652: CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED 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 INFORMATION IN THIS COMPLAINT (B)(4) HAS BEEN EVALUATED FOR THE MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE. THE BATCH 6000798 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE REFERENCE SAMPLES FOR BATCH 6000798 WERE PREVIOUSLY TESTED IN (B)(4) ON 10/JAN/2024. DEVICE HISTORY RECORD (DHR) REVIEW: PACKING LOT 1890652 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 103 IN THE LINE L-1, ON 31/MAR/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 RELATED TO THE MALFUNCTION REPORTED, NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 11/AUG/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND BENT UPON REMOVAL FROM INFUSION SITE AND LOT 6000798 AND NO MORE COMPLAINTS HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6000798 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: THIS IS A COMPLAINT WHICH IS BEING ADDRESSED AS PART OF A CORRECTIVE AND PREVENTIVE ACTION (CAPA) 1768101: "AUTOSOFT 90, KINKED SOFT CANNULA ISSUES WHICH HAS BEEN OPENED AS A RESULT OF TRENDING ACTIVITIES. THIS COMPLAINT IS A REPORTABLE WITH VALID LOT NUMBER/PRODUCT CODE

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT ENCOUNTERED 24 INFUSION SET CANNULA BENT ON (B)(6) 2024 AFTER 3 OR MORE HOUR OF INSERTION. INFUSION SET HAS BEEN USED FOR 1.5 DAYS. INSERTION SITE WAS ABDOMEN AND ARM. REGULARLY ROTATE SITE LOCATION. CUSTOMER CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE BLOOD GLUCOSE LEVEL WAS HIGH. THEREFORE, PATIENT WAS TREATED WITH CORRECTION VIA BOLUS AND PATIENT WAS TAKEN TO EMERGENCY ROOM. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. UNOMEDICAL 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 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
    2251055 AUTOSOFT 90 UNO INSET II 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002819 6000798 05705244018181

    Patients

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