BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19759800 · Received July 17, 2024

    Report

    Report Number
    3003442380-2024-15041
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 13, 2024
    Report Date
    April 3, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR RETRACTION: AN INITIAL SUPPLEMENT MEDICAL DEVICE REPORT (MDR) WAS SUBMITTED ON JANUARY 24, 2025, WITH THE MANUFACTURING REPORT NUMBER 3003442380-2024-05550. AS NO SUPPLEMENT WAS REQUIRED FOR THE CASE SO, MDR IS BEING FILED TO RETRACT THE PREVIOUS REPORT THAT CONTAINED THE WRONG MFR.

    Additional Manufacturer Narrative · 0

    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 REFERENCE SAMPLES FOR THE LOT 6005583 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE (B)(4) ON 04/FEB/2025. THE REFERENCE SAMPLES WERE VISUAL INSPECTED AND TESTED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE 1891761 COMPLAINT TEST REPORT.PDF ATTACHED IN THIS RECORD. ACCORDING TO ADDITIONAL TESTS FOR THE REFERENCE SAMPLES WERE DOCUMENTED FOR THE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, UNDER SECTION 06.45. THE VISUAL INSPECTION AND FLOW TEST WERE FOUND WITHIN SPECIFICATIONS. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005583 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 111 MANUFACTURED IN THE LINE 1, ON 22/FEB/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 DATABASE ON 03/APR/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6005583 AND OTHER 1 COMPLAINTS HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6005583 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, 1 OTHER 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

    TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H11.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT THE PATIENT FACED KINKED CANNULA EVENT ON (B)(6) 2024. THE EVENT OCCURRED WITHIN THREE HOURS OF INSERTION. THE INFUSION SET WAS INSERTED IN ABDOMEN. BLOOD GLUCOSE LEVEL REPORTED DURING EVENT WAS 15 MMOL/L. UNOMEDICAL DO NOT SEE 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
    749076 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6005583 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female