BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKFINE 32GX4MM DONGBAO 7CT

    MDR report key: 16553551 · Received March 16, 2023

    Report

    Report Number
    3002806818-2023-00003
    Event Type
    Injury
    Date Received
    March 16, 2023
    Date of Event
    February 19, 2023
    Report Date
    March 16, 2023
    Manufacturer
    YPSOMED AG
    Product Code
    FMI
    PMA / PMN Number
    K171984
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INSULIN INJECTION AT HOME BY THE PATIENT, THE INSULIN COULD NOT BE DELIVERED DUE TO A BLOCKED NEEDLE. THIS LEAD TO THE PATIENT ENDING UP IN A COMA DUE TO HYPERGLYCEMIA. THE PATIENT WAS SENT IMMEDIATELY TO THE HOSPITAL FOR TREATMENT AND CARE. THE PATIENT'S VITAL SIGNS STABILIZED AFTERWARDS. THE REVIEW OF MANUFACTURING HISTORY SHOWED NO ABNORMALITIES OR DEVIATIONS FROM THE VALIDATED MANUFACTURING PROCESS FOR THE MAIN BATCH 211488. TESTS WERE ALSO COMPLETED ON RETENTION SAMPLES. ONE TEST INCLUDED REMOVAL OF THE FRONT END AND THE BACK END SILICON, AND THEN PERMEABILITY WAS CHECKED TO 100%. AIR STREAM IS DUCTED THROUGH THE CANNULA. AN AIR FLOW SENSOR MEASURES THE FLOW STREAM TO CHECK FOR ANY BLOCKAGE OR NARROWING OF THE FLOW PATH DURING THE ASSEMBLY PROCESS. NO ISSUES WERE FOUND. A HANDLING TEST WAS ALSO CONDUCTED AND FLUID COULD BE ADMINISTERED WITHOUT ISSUE.

    Description of Event or Problem · 0

    DURING AN INSULIN INJECTION AT HOME BY THE PATIENT, THE INSULIN COULD NOT BE DELIVERED DUE TO A BLOCKED NEEDLE. THIS LEAD TO THE PATIENT ENDING UP IN A COMA DUE TO HYPERGLYCEMIA. THE PATIENT WAS SENT IMMEDIATELY TO THE HOSPITAL FOR TREATMENT AND CARE. THE PATIENT'S VITAL SIGNS STABILIZED AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437397 CLICKFINE 32GX4MM DONGBAO 7CT PEN NEEDLE FMI YPSOMED AG CLICKFINE 32GX4MM DONGBAO 7CT 211488-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization