BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3191542 · Received June 26, 2013

    Report

    Report Number
    2432235-2013-00292
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 18, 2013
    Report Date
    June 18, 2013
    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

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE SITE. THE CUSTOMER HAD REPLACED THE DILUTION PROBE PIPETTE, REAGENT PROBE PIPETTE 1 AND REAGENT PROBE PIPETTE 2 AFTER WHICH THERE WERE NO MORE DISCORDANT CALCIUM RESULTS. THE CAUSE OF THE DISCORDANT, FALSELY LOW CALCIUM RESULTS WAS DUE TO MALFUNCTIONS IN THE PROBE PIPETTES . THE FSE MONITORED THE INSTRUMENT FOR ANOTHER DAY AND THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CALCIUM RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE RELEASED TO THE PHYSICIAN(S). THE PATIENT SAMPLES WERE REPEATED ON ANOTHER ADVIA 1800 INSTRUMENT AND RESULTS WERE HIGHER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CALCIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290315 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1