BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19736682 · Received July 13, 2024

    Report

    Report Number
    3003442380-2024-13976
    Event Type
    Malfunction
    Date Received
    July 13, 2024
    Date of Event
    May 28, 2024
    Report Date
    January 3, 2025
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244016620
    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 1911397- MDR 3003442380-2024-13976- DEVICE 2 OF 4.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT (B)(4). 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 COMPLAINT (B)(4) HAS BEEN EVALUATED. THE BATCH 6003982 IN QUESTION WAS MANUFACTURED AT THE REYNOSA SITE. INVESTIGATION PROCESS OF THE COMPLAINT WAS CARRIED OUT IN ACCORDANCE WITH WORK INSTRUCTION GUIDANCE FOR VISUAL TESTING FOR COMPLAINTS AREA VERSION 1 AND WORK INSTRUCTION GUIDANCE FOR FUNCTIONAL TESTING FOR COMPLAINTS AREA VERSION 1 FOR THE CODE "SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE." COMPLAINT INVESTIGATIONS. PHOTO/SAMPLE WAS NOT PROVIDED. IN ORDER TO TEST THE PRODUCT, THE REFERENCE SAMPLES FROM THE LOT HAVE BEEN REQUESTED. THE FOLLOWING TEST WAS PERFORMED: VISUAL TEST ACCORDING TO WORK INSTRUCTION VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. FUNCTIONAL TEST 1 ACCORDING TO WORK INSTRUCTION VERSION 1 ON REFERENCE SAMPLES, 10 SAMPLES OUT 10 SAMPLES PASSED THE TEST. A BATCH RECORD REVIEW WAS CONDUCTED RESULTING IN THE FOLLOWING: - THE LOT 6003982 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION VERSION 69 MANUFACTURED IN THE MACHINE L138, ON 02/NOV/2023, WITH A TOTAL OF (B)(4) UNITS. REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE RELATED PROCESS HAD BEEN FULFILLED AND MET THE REQUIREMENTS. A QUERY WAS RUN IN TRACKWISE AGAINST MALFUNCTION CODE "SOFT CANNULA FOUND KINKED UPON REMOVAL FROM INFUSION SITE." AND LOT 6003982 AND OTHER ZERO COMPLAINT HAS BEEN REGISTERED IN TRACKWISE SINCE THE LAST 12 MONTHS. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, OTHER ZERO COMPLAINT RECEIVED ON THE LOT IN QUESTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVELLIENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET CANNULA KINKED EVENTS ON 22-MAY-2024. 28-MAY-2024, 28-MAY-2024 AND 03-JUN-2024. THE EVENT OCCURRED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS AT ABDOMEN AND THIGH. THE PATIENT REPLACED INFUSION SET AND REMAINED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862311 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001680 6003982 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male