BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX HEMATOLOGY SYSTEM ACCESSORIES

    MDR report key: 2434653 · Received January 30, 2012

    Report

    Report Number
    1422681-2012-00001
    Event Type
    Other
    Date Received
    January 30, 2012
    Date of Event
    December 29, 2011
    Report Date
    January 3, 2012
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K920544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHANOL IS NOT MANUFACTURED OR DISTRIBUTED BY SYSMEX, BUT IS USED TO CLEAN THE CASSETTES USED ON THE SP-1000I. THE MSDS FOR METHANOL INDICATES THE POTENTIAL TOXIC HEALTH EFFECTS OF INHALATION AND DESCRIBES THE METHODS OF PERSONAL PROTECTION AND EXPOSURE CONTROL TO PREVENT EXPOSURE TO THESE HEALTH HAZARDS. DURING F/U ON (B)(4) 2012, WITH THE LABORATORY MGR, SHE REPORTED THAT THE USER INVOLVED IN THE INCIDENT WAS HOSPITALIZED FOR ONE DAY, DID NOT SUFFER ANY LINGERING AFFECTS AND IS BACK TO WORK. ALTHOUGH THE LAB MGR DID NOT DESCRIBE THE METHOD IN WHICH THE USER WAS EXPOSED TO THE METHANOL, SHE REPORTED THEY HAVE SINCE CHANGED THEIR POLICY FOR CLEANING CASSETTES TO INCLUDE USING A FACE SHIELD AND BUTYL GLOVES, AND TO USE A SINK IN A VENTILATED HOOD. NO SIMILAR INCIDENTS HAVE OCCURRED SINCE THIS CHANGE TO THEIR PROCEDURE.

    Description of Event or Problem · 1

    THE LAB MANAGER REPORTED A USER OF A SYSMEX SP-1000I (SLIDE PREPARER-STAINER) COMPONENT OF THE SYSMEX XE-5000 ALPHA-N BECAME LIGHT-HEADED WHILE PERFORMING THE ROUTINE DAILY CLEANING OF THE SLIDE CASSETTES WITH METHANOL. THE USER FELT FAINT AND REPORTED DIFFICULTY WITH READING, SO HE STOPPED WORKING WITH THE CASSETTES AND HAD A COWORKER RELIEVE HIM. HE STATED THE INCIDENT OCCURRED AT 01:30 AM, AND REPORTED IT TO THE LAB MANAGER AT 05:30 AM. THE USER WENT TO THE EMERGENCY DEPT AT 07:00 AM, AND WAS HOSPITALIZED FOR ONE DAY AND RELEASED. NO LINGERING AFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSMEX HEMATOLOGY SYSTEM ACCESSORIES XE-5000 ALPHA-N GKZ SYSMEX CORPORATION SP-1000I

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization