BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21271510 · Received January 30, 2025

    Report

    Report Number
    3003442380-2025-00034
    Event Type
    Malfunction
    Date Received
    January 30, 2025
    Date of Event
    December 23, 2024
    Report Date
    June 3, 2025
    Manufacturer
    UNOMEDICAL UM-D
    Product Code
    FPA
    UDI-DI
    05705244016712
    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 6008159 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 2121214 ON 03/MAR/2025. THE REFERENCE SAMPLES WERE VISUAL INSPECTED AND TESTED FOR FLOW. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS AS PER (B)(4) TEST REPORT. DEVICE HISTORY RECORD (DHR) REVIEW: THE 6008159 WAS MANUFACTURED ACCORDING TO THE DOCUMENT VERSION 115 ON THE PACKING PROCESS IN THE LINE INSET 7 ON 14/JUL/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 03-JUN-2025 AGAINST MALFUNCTION CODE OCCLUSION IN THE TUBING AND/OR TUBING CONNECTORS AND LOT 6008159 AND ONE MORE COMPLAINT HAVE BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6008159 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: AS A RESULT OF THE FOLLOWING: NO DEFECT ON TESTS FOR RETENTION SAMPLES, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION, NO MORE COMPLAINTS 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 EXPERIENCED THERE WAS A BLOCKAGE IN THE TUBING ON (B)(6) 2024, WHICH RESULTED IN ELEVATED BLOOD GLUCOSE, THEREFORE PATIENT HAD RECEIVED CORRECTION BOLUS VIA PUMP. THE PATIENT CHANGED SUPPLIES AS NECESSARY AND RESUMED INSULIN THERAPY. 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
    792246 AUTOSOFT XC UNO INSET I 60/6 BLUE TCAP 10PK INT FPA UNOMEDICAL UM-D 1001683 6008159 05705244016712

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male