BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 2933933 · Received January 29, 2013

    Report

    Report Number
    2432235-2013-00039
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    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). AFTER ANALYSIS OF THE DATA, THE TSC SPECIALIST DETERMINED THAT THE DISCORDANT RESULTS WERE SPECIFIC TO ONE SAMPLE TUBE, AND THE CORRECT RESULTS WERE OBTAINED WHEN AN ALTERNATE SAMPLE TUBE FROM THE SAME PATIENT WAS RUN ON THE SAME INSTRUMENT. THE CAUSE OF THE DISCORDANT PHOSPHATE, URATE, CREATININE, UREA, POTASSIUM, AND EGFR RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) RESULT AND DISCORDANT, FALSELY ELEVATED PHOSPHATE, URATE, CREATININE, UREA, AND POTASSIUM RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 2400 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE PATIENT WAS ADMITTED TO THE HOSPITAL AND REDRAWN. THE PATIENT'S RESULTS WERE WITHIN NORMAL RANGES AT THE HOSPITAL LABORATORY. THE INITIAL LABORATORY THEN RAN A DIFFERENT SAMPLE TUBE FROM THE PATIENT, AND THE RESULTS OBTAINED MATCHED THE HOSPITAL LABORATORY RESULTS. THE LABORATORY RERAN THE SAMPLE TUBE THAT THE DISCORDANT RESULTS WERE OBTAINED FROM AND THE CREATININE, UREA, AND POTASSIUM RESULTS WERE ALL ELEVATED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39669 ADVIA 2400 ADVIA 2400 JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1