BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1800

    MDR report key: 5204835 · Received November 5, 2015

    Report

    Report Number
    2432235-2015-00520
    Date Received
    November 5, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) REQUESTING A MATERIAL SAFETY DATA SHEET (MSDS) ON CUVETTE WASH SOLUTION. CCC HAS PROVIDED IT. UPON FOLLOW-UP, THE LABORATORY MANAGER STATED THAT THE OPERATOR IS ALL RIGHT. THE LABORATORY INSTITUTED A CHANGE FOR OPERATORS TO WEAR FACE SHIELDS WHEN PERFORMING MAINTENANCE. THE CAUSE OF THE OPERATOR BEING SPLASHED IN THE FACE BY CUVETTE WASH SOLUTION WAS A HUMAN FACTOR ISSUE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN EMPLOYEE WAS SPLASHED IN THE FACE WITH CUVETTE WASH SOLUTION WHILE PERFORMING MAINTENANCE ON THE ADVIA 1800 INSTRUMENT. THE OPERATOR WAS USING PERSONAL PROTECTIVE EQUIPMENT (PPE); LAB COAT, GLOVES, AND SAFETY GLASSES, BUT NO FACE SHIELD. THERE WAS NO MEDICAL TREATMENT OR INJURIES REPORTED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE OPERATOR BEING SPLASHED IN THE FACE WITH CUVETTE WASH SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736063 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1