BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 20265991 · Received September 20, 2024

    Report

    Report Number
    3003442380-2024-26377
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 17, 2024
    Report Date
    December 5, 2024
    Manufacturer
    UNOMEDICAL A/S
    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 INVESTIGATION ASSOCIATED WITH RELATED EVENT DATABASE 1979395 HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKETING SURVEILLANCE (PMS) PRODUCT TRENDS AND MALFUNCTION ACCORDING TO THE MARKET QUALITY REVIEW (OMQR) PROCEDURE. THE IDENTIFIED FOR MALFUNCTION CODE, TUBING IS DAMAGED (E.G., KINKED, DEFORMED, TWISTED, COLLAPSED, OR PINCHED), IS NOT ASSOCIATED WITH A DESIGN OR MANUFACTURING-RELATED COMPLAINT ISSUE. THEREFORE, A DETAILED INVESTIGATION OR INSPECTION OF REFERENCE SAMPLES IS NOT REQUIRED. BATCH REVIEW: LOT 6000683 WAS MANUFACTURED ON 24-MAY-2023, IN MACHINE L182, WITH A TOTAL OF 29,400. THE BATCH RECORD WAS REVIEWED TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED, AND NO ISSUES WERE FOUND. REVIEW OF THE BATCH RECORD SHOWED THAT ALL RELEVANT TESTS REQUIRED DURING THE MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN FULFILLED AND MET THE REQUIREMENTS. NO DISCREPANCY RELATED TO THIS ISSUE WAS FOUND WITHIN THE DOCUMENTATION. CONCLUSION SUMMARY OF THE RELATED EVENT. DUE TO THE FOLLOWING BATCH RECORD REVIEW YIELDING NO DISCREPANCIES AND NO NON-CONFORMANCE (NC) WAS GENERATED DURING PRODUCTION. IN THE MANUFACTURING PROCESS THE TUBING IS INSPECTED AGAINST SPECIFICATIONS BEFORE RELEASED FOR PRODUCTION. HOWEVER, DURING USE COULD ALSO ACCIDENTALLY KINK THE TUBING BY WINDING IT OR GETTING THE TUBING CAUGHT ON OR IN SOMETHING. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED INFUSION SET TUBING BENT. INFUSION SET WAS IN USE FOR LESS THAN A DAY. THE BLOOD GLUCOSE WAS REPORTED 400 - 500 MG/DL AND TREATED WITH MULTI-DAILY INJECTION (MDI). NO FURTHER INFORMATION.

    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
    2329885 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6000683 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female