BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3003044483-2008-00001

    MDR report key: 1260323 · Received November 10, 2008

    Report

    Report Number
    3003044483-2008-00001
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Product Code
    GKR
    PMA / PMN Number
    K032203
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY ANALYSIS INDICATES THAT THE PT'S POOR PERIPHERAL CIRCULATION HAS CONTRIBUTED TO A NON-REPRESENTATIVE CAPILLARY SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GKR

    Patients

    Seq Age Sex Outcome Treatment
    1