BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21077830 · Received January 6, 2025

    Report

    Report Number
    3003442380-2024-35955
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 2, 2024
    Report Date
    March 5, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244016651
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 6005733 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE PR 2063255 ON 20/JAN/2025. THE REFERENCE SAMPLES WERE TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER THE TEST REPORT DATABASE (B)(4) COMPLAINT TEST REPORT. AS ADDITIONAL TESTS FOR THE REFERENCE SAMPLES WERE DOCUMENTED FOR THE MALFUNCTION SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE, UNDER SECTION 06.45 AND THE VISUAL INSPECTION WAS FOUND WITHIN SPECIFICATIONS. COMPLAINT INVESTIGATIONS. 6 UNUSED SETS WERE PROVIDED AND THERE IS VISIBLE NO DAMAGES OR DEFECTS. THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. TEST RESULTS: VISUAL TEST ACCORDING TO WORK INSTRUCTION (WI) VERSION 2 ON SAMPLES RETURNED, 6 SAMPLES OUT 6 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 1 ON SAMPLES RETURNED, 6 SAMPLES OUT 6 SAMPLES PASSED THE TEST. VISUAL TEST ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. FUNCTIONAL FLOW TEST 1 ACCORDING TO WI VERSION 1 ON REFERENCE SAMPLES, 5 SAMPLES OUT 5 SAMPLES PASSED THE TEST. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005733 WAS MANUFACTURED ACCORDING TO THE WI VERSION 111 MANUFACTURED IN THE LINE 5, ON 01/MAR/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, NOR MAINTENANCE EVENTS WERE RECORDED. TRENDING: A QUERY WAS RUN IN DATABASE ON 27/FEB/2025 AGAINST MALFUNCTION CODE SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE AND LOT 6005733 AND ANOTHER 1 COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6005733 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR SAMPLES RETURNED AND REFERENCE SAMPLES, HARM NO REPORTABLE, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, ANOTHER 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2024. EVENT OCCURRED WITHIN 3 OR LESS THAN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT ABDOMEN. BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE EVENT. THEREFORE, PATIENT TOOK CORRECTION INJECTION VIA MULTIPLE DAILY INJECTION FOR THE TREATMENT. PATIENT REPLACED INFUSION SET 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
    1064173 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001681 6005733 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female