BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 21064651 · Received January 3, 2025

    Report

    Report Number
    3003442380-2024-35712
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    August 1, 2024
    Report Date
    May 21, 2025
    Manufacturer
    UNOMEDICAL UM-D
    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

    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 6002758 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 1834172 ON 23-FEB-2025 TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. TEST RESULT WAS WITHIN SPECIFICATIONS AS PER THE TEST REPORT 1834172. DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005988 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 LINE L-5, ON 14/AUG/2023, 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 20/MAY/2025 AGAINST MALFUNCTION CODE INCORRECT INSERTION OF THE SOFT CANNULA AND LOT 6002758 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002758 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVILLENCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    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 6002758 HAVE ALREADY BEEN PREVIOUSLY TESTED IN THE 1834172 ON 23-FEB-2025. TEST RESULTS: THE REFERENCE SAMPLES WERE VISUALLY INSPECTED. TEST RESULT WAS WITHIN SPECIFICATIONS AS PER THE TEST REPORT (B)(4). DEVICE HISTORY RECORD (DHR) REVIEW: THE LOT 6005988 WAS MANUFACTURED ACCORDING TO THE WORK INSTRUCTION (WI) VERSION 106 LINE L-5, ON 14/AUG/2023, 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 20/MAY/2025 AGAINST MALFUNCTION CODE INCORRECT INSERTION OF THE SOFT CANNULA AND LOT 6002758 AND NO OTHER COMPLAINT HAS BEEN REGISTERED IN DATABASE FOR THE SAME LOT 6002758 AND MALFUNCTION CODE. CONCLUSION SUMMARY OF THE RELATED EVENT: HARM NO REPORTABLE, NO DEFECT ON TESTS, NO NON-CONFORMANCE (NC) RAISED DURING PRODUCTION AND MALFUNCTION CODE, NO FURTHER ACTIONS ARE REQUIRED. THEREFORE, THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE ON MARKET QUALITY REVIEW (OMQR) PROCEDURE.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA DID NOT INSERT, IT REMAINED OUTSIDE EVENT ON (B)(6) 2024. THE EVENT OCCURRED THREE OR MORE HOURS AFTER INSERTION. THE INSERTION SITE WAS ABDOMEN. THE INFUSION SET WAS IN USE FOR LESS THAN ONE DAY. THE BLOOD GLUCOSE LEVEL WAS HIGH (SPECIFIC VALUE UNKNOWN) AND THE PATIENT WAS TREATED WITH CORRECTION BOLUS VIA PUMP. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    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
    1116726 AUTOSOFT XC UNO INSET I 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL UM-D 1001680 6002758 05705244016620

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male