BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 4100048 · Received September 18, 2014

    Report

    Report Number
    2432235-2014-00552
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER STATED TO CCC THAT A FEW HOURS AFTER CALIBRATION, QUALITY CONTROLS DRIFTED OUT OF RANGE. THE CUSTOMER REPLACED THE CHLORIDE ELECTRODE AND REPEATED PATIENT SAMPLES. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CORRECTED THE GROUND WIRE AT THE SAMPLE PATH AND REPLACED THE CHLORIDE ELECTRODE. THE CAUSE OF THE DISCORDANT, FALSELY LOW CHLORIDE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW CHLORIDE (CL) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AFTER TROUBLESHOOTING, RESULTING 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 CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577852 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1