BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19612683 · Received June 26, 2024

    Report

    Report Number
    3003442380-2024-10340
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    April 26, 2024
    Report Date
    November 7, 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

    INITIAL AND FINAL MDR (B)(4). DEVICE 2 OF 2. E1: PATIENT COUNTRY: UNITED STATES.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 -(B)(4). CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4 AND DEVICE MANUFACTURER DATE UNDER H4. 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 (B)(4) 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 ON MARKET QUALITY REVIEW (OMQR). THE IDENTIFIED MALFUNCTION ADHESIVE PATCH LIFTS OR DETACHES DURING USE, 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 6003933 WAS MANUFACTURED ON 28-OCT-2023, IN MACHINE L158, WITH A TOTAL OF (B)(4). 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. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT. THE ACRYLIC GLUE ON THE ADHESIVE IS NOT APPLIED BY CONVATEC AND THE ADHESIVE MATERIAL HAS BEEN MANUFACTURED AND INSPECTED IN ACCORDANCE WITH ALL SPECIFICATIONS, BATCH DOCUMENTATION AND THE REQUIREMENTS ACCORDING TO 21 CFR PART 820: QUALITY SYSTEM REGULATION AND ISO EN 13485:2016: MEDICAL DEVICES-QUALITY MANAGEMENT SYSTEMS.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT TWO INFUSION SETS FELL OFF DURING USE "WHICH" LED TO HIGH BLOOD GLUCOSE LEVEL OF 150-200MG/DL ON (B)(6) 2024. THE INFUSION SET IN USE FOR 1 TO 1.5 DAYS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION 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
    595862 AUTOSOFT XC UNO INSET I 60/9 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1001681 6003933 05705244016651

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female