BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 4131980 · Received October 1, 2014

    Report

    Report Number
    2432235-2014-00576
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CLEANED AND FLUSHED THE WASH UP DOWN AND DILUTION WASH UP DOWN, REPLACED A FILTER AND SEALS ON THE SAMPLE PROBE AND DILUTION PROBE PUMPS, AND CLEANED AND CALIBRATED ALL PROBES AND MIXERS. THE CSE RAN A DIAGNOSTICS TEST, WHICH PASSED. THE CAUSE OF THE DISCORDANT CALCIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CALCIUM RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS FOR TWO OF THE PATIENT SAMPLES WERE REPORTED TO THE PHYSICIAN(S), BUT WERE CORRECTED IMMEDIATELY. THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND AN ALTERNATE INSTRUMENT AND ALL RESULTED HIGHER ON BOTH. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610635 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1