BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 3898622 · Received June 26, 2014

    Report

    Report Number
    2432235-2014-00382
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CGZ
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER STATED THAT AFTER REPLACING THE ION SELECTIVE ELECTRODE (ISE) BUFFER, THEY DID NOT PERFORM ISE CALIBRATIONS PRIOR TO RUNNING PATIENT SAMPLES. THE CUSTOMER RE-CALIBRATED THE ISE AND RAN QUALITY CONTROLS, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED CL RESULT IS A USER ERROR. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CHLORIDE (CL) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULT WAS RELEASED TO THE PATHOLOGIST(S), WHO QUESTIONED IT. THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT, RESULTING LOWER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374577 ADVIA 2400 CLINICAL CHEMISTRY ANALYZER CGZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1