BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    MDR report key: 4297497 · Received December 4, 2014

    Report

    Report Number
    2432235-2014-00708
    Event Type
    Malfunction
    Date Received
    December 4, 2014
    Date of Event
    November 9, 2014
    Report Date
    November 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THE ISSUE TO DETERMINE WHAT TYPE OF CLEANING FLUID WAS SPLASHED IN THE CUSTOMER'S FACE. THE CUSTOMER DID WASH THEIR FACE AFTER BEING SPLASHED BY THE CLEANING SOLUTION. THE CAUSE OF THE CLEANING SOLUTION SPLASHING ONTO THE CUSTOMER'S FACE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR 2432235-2014-00708 ON DECEMBER 4, 2014. ADDITIONAL INFORMATION (DECEMBER 17, 2014): THE SIEMENS HEALTHCARE DIAGNOSTICS INC. TECHNICAL AND APPLICATION SUPPORT MANAGER CLARIFIED THAT THE CLEANING SOLUTION THAT WAS SPLASHED IN THE CUSTOMER'S FACE WAS CONCENTRATED CLOROX (8.25%). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER BEING SPLASHED IN THE FACE WITH CONCENTRATED CLOROX (8.25%).

    Description of Event or Problem · 1

    THE CUSTOMER WAS USING A CLEANING SOLUTION TO REMOVE A CLOT ON THE ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER. THE CLEANING SOLUTION SPLASHED IN THE CUSTOMER'S FACE. THE CUSTOMER WAS WEARING PROTECTIVE CLOTHING, GLOVES AND A FACE SHIELD BUT WAS NOT WEARING SAFETY GLASSES. IT IS UNKNOWN WHAT THE CLEANING SOLUTION WAS. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE CUSTOMER BEING SPLASHED IN THE FACE WITH THE CLEANING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784241 ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120I WITH DUAL ASPIRATE AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1