BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOSOFT XC

    MDR report key: 19997673 · Received August 16, 2024

    Report

    Report Number
    3003442380-2024-21384
    Event Type
    Malfunction
    Date Received
    August 16, 2024
    Date of Event
    June 1, 2024
    Report Date
    October 30, 2024
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    UDI-DI
    05705244022386
    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).

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 01 - MDR (B)(4) - MDR 3003442380-2024-21384. 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 1942079 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, SOFT CANNULA FOUND KINKED 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 6005142 WAS MANUFACTURED ON 17-JAN-2024, IN LINE 3, 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

    REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-JUNE-2024, IT WAS REPORTED THAT THE PATIENT ENCOUNTERED SEVEN INFUSION SETS CANNULA KINKED EVENTS WITHIN 3 HOURS OF INSERTION. THE SITE OF LOCATION WAS ABDOMEN OR ARM. THE BLOOD GLUCOSE WAS REPORTED HIGH AND TREATED WITH BOLUS VIA PUMP. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. 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
    2353580 AUTOSOFT XC UNO INSET I 12/6 GREY TCAP 10PK INT FPA UNOMEDICAL A/S 1006922 6005142 05705244022386

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Female