BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19429337 · Received May 30, 2024

    Report

    Report Number
    3003442380-2024-04547
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    April 23, 2024
    Report Date
    November 12, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS MDR IS BEING SUBMITTED TO CORRECT THE SUBMITTED EXPIRATION DATE UNDER D4. 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 EVENT1874923 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 SOFT CANNULA FOUND CRIMPED UPON REMOVAL FROM INFUSION SITE, 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 6003858 WAS MANUFACTURED ON 25-OCT-2023, IN MACHINE L149, 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. DURING MANUFACTURING OF THE CANNULA PART, THE SOFT CANNULA IS KEPT STRAIGHT BY THE INTRODUCER NEEDLE, NO SAMPLES WERE RETURNED FOR INSPECTION. HOWEVER, DURING USE IN GENERAL AND SPECIFICALLY DURING INSERTION MAY ACCIDENTALLY KINK THE SOFT CANNULA. NO FURTHER ACTION IS REQUIRED FOR THIS COMPLAINT, IF USED/UNUSED SAMPLES ARE RECEIVED, APPROPRIATE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN OCCLUSION ISSUE WITH THE CANNULA INFUSION SET SPECIFICALLY INFUSION SET CANNULA WAS CRIMPED. THE PATIENT RESOLVED THE ISSUE BY CHANGING THE INFUSION SET CANNULA AND RESUMING INSULIN. THE SYMPTOMS WERE NOTICED WITHIN 3 HOURS OF INSERTION, AND THE SITE WAS IN THE ABDOMEN. THE PATIENT REGULARLY ROTATES SITE LOCATIONS, AND THE SITE AREA WAS NOT IMPACTED. 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
    1099300 AUTOSOFT XC INSET I 2-PACK 60/9 GREY TCAP FPA UNOMEDICAL A/S 6003858

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male