BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX CA-1500

    MDR report key: 467743 · Received June 16, 2003

    Report

    Report Number
    1422681-2003-00002
    Event Type
    Other
    Date Received
    June 16, 2003
    Date of Event
    April 20, 2003
    Report Date
    June 5, 2003
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    JPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN/CUSTOMER INJURED THEMSELVES WHILE CLEANING THE CAP PIERCER PROBE ON A SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER DURING ROUTINE PREVENTIVE MAINTENANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX CA-1500 AUTOMATED COAGULATION ANALYZER JPA SYSMEX CORPORATION CA-1500 110113

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other