BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT 90

    MDR report key: 19947400 · Received August 9, 2024

    Report

    Report Number
    3003442380-2024-19921
    Event Type
    Malfunction
    Date Received
    August 9, 2024
    Date of Event
    June 26, 2024
    Report Date
    September 10, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244018129
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - (B)(4) - MDR 3003442380-2024-19921. 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 (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 MARKET QUALITY REVIEW (OMQR) PROCEDURE. THE IDENTIFIED FOR MALFUNCTION CODE, ADHESIVE PATCH LIFTS OR DETACHES DURING USE, WAS 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 6003504 WAS MANUFACTURED ON 01-OCT-2023, IN MACHINE L171, 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.

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR (B)(4).- MDR DEVICE 3 OF 4.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS FELL OFF DURING USE EVENTS ON 26-JUN-2024. THE SET WAS IN USE FOR A FEW HOURS. THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENTS WAS 22MMOL AND PATIENT RESOLVED ALL THE EVENTS BY REPLACING INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1646532 AUTOSOFT 90 UNO INSET II 60/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1002817 6003504 05705244018129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown