BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOSOFT 90

    MDR report key: 20170631 · Received September 9, 2024

    Report

    Report Number
    3003442380-2024-24585
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    July 20, 2024
    Report Date
    August 13, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    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

    (B)(4) - DEVICE 1 OF 7.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) MDR 3003442380-2024-24585. 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. THE BATCH 6002381 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION (WI) GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 3 AND (WI) GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 2 FOR THE CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE . COMPLAINT INVESTIGATION. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. REFERENCE SAMPLES TEST RESULTS: VISUAL TEST ACCORDING TO (WI) VERSION 3 ON REFERENCE SAMPLES, 10/10 SAMPLES PASSED THE TEST. ON THE FUNCTIONAL AIR FLOW TEST, ACCORDING TO (WI) VERSION 2 WAS PERFORMED AND 5/5 SAMPLES PASSED THE TEST FIVE REFERENCE SAMPLES WERE NOT ABLE TO BE TEST FOR FLOW DUE TO THE SAMPLES WERE USED IN A SPECIAL INVESTIGATION. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: PACKAGING LOT: THE LOT 6002381 WAS MANUFACTURED ACCORDING TO THE (WI) VERSION 106 MANUFACTURED IN THE LINE INSET 1, ON 20/JUL/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; NO MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 25-JUL-2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6002381 AND ONE MORE COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002381 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: ON THE INVESTIGATION ON REFERENCE SAMPLES, NO ISSUE WERE FOUND RELATED TO SOFT CANNULA, HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ONE MORE COMPLAINT WAS RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION, NO FURTHER ACTION ARE REQUIRED, 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 STATES. IT WAS REPORTED THAT PATIENT FACED CANNULA ISSUES OF WITH SEVEN INFUSION SETS. THE CANNULAS WERE KINKED. THE EVENT OCCURRED ON 20-JUL-2024 TO 03-AUG-2024. PATIENT NOTICED SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. INFUSION SETS WERE USED FOR 5 HOURS. THE INSERTION OF SITE WAS BACK. PATIENT REGULARLY ROTATED SITE LOCATION. PATIENT CONFIRMED THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF THE EVENT. THEREFORE, PATIENT FIRST VISIT EMERGENCY ROOM AND LATER WAS HOSPITALIZED. PATIENT WAS TREATED WITH IV FLUIDS OF SALINE AND INSULIN. PATIENT CHANGED SITE AND TOOK INSULIN VIA INSULIN PEN. PATIENT WAS FOUND TO BE POSITIVE FOR KETONES. PATIENT REPLACED 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
    563643 AUTOSOFT 90 UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6002381 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Hospitalization