BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800 ANALYZER

    MDR report key: 7293808 · Received February 23, 2018

    Report

    Report Number
    2432235-2018-00087
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 23, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414553177
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE DECONTAMINATED THE INSTRUMENT AND REBUILT THE PUMPS. THE CSE FOUND THE REACTION TRAY WASH UNIT DRAIN VALVE 1 (CDEV1) ON THE REACTION TRAY WASH UNIT (WUD) NOT OPENING AND REPLACED THE VALVE; CLEANED AND CHECKED FILTRATION OF MIX 1 WASH PORT, CHECKED WUD ASPIRATORS, REPLACED THE LARGE WATER PUMP (LWP) FILTER, AND ADJUSTED THE ALIGNMENT OF THE REAGENT PIPETTING PROBE 1 (RPP1) WASH PORT. THE CSE CLEANED AND VERIFIED FULL DRAIN OF RPP1 WASH PORT, INSTALLED THE EXTERNAL DEGASSER AND RAN QC AS WELL AS MULTIPLE SAMPLES. ALL PASSED AND NO OUTLIERS WERE SEEN. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) ON THE TWO PATIENT SAMPLES IS UNKNOWN. NO FURTHER ISSUES WITH CO2_C AFTER SERVICE WAS DISPATCHED. THE DEVICE IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS WERE OBTAINED ON 2 SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND THEY RESULTED LOWER. 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 ELEVATED CARBON DIOXIDE CONCENTRATED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136905 ADVIA 1800 ANALYZER ADVIA CHEMISTRY JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 00630414553177

    Patients

    Seq Age Sex Outcome Treatment
    1