BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800 ANALYZER

    MDR report key: 20961684 · Received December 18, 2024

    Report

    Report Number
    2432235-2024-00351
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 26, 2024
    Report Date
    January 8, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 2432235-2024-00351 ON 18-DEC-2024. ADDITIONAL INFORMATION (26-DEC-2024): SIEMENS EVALUATED THE EVENT AND DETERMINED THAT POOR WASTE DRAINING BY REACTION TRAY WASH UNIT (WUD) AND DILUTION REACTION TRAY WASH UNIT (DWUD) POTENTIALLY CONTRIBUTED TO THE ERRONEOUS CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS. THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES IN H6 WERE UPDATED TO REFLECT THE ADDITIONAL INFORMATION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT ERRONEOUS CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE CUSTOMER TURNED OFF THE ANALYZER. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. DURING THE VISIT, THE CSE INSPECTED THE INSTRUMENT, CLEARED PARTIAL CLOG ON THE REACTION TRAY WASH UNIT (WUD) OVERFLOW LINE, INSTALLED LARGE WATER PUMP (LWP) FILTER RETROFIT KIT, OBSERVED SLUGGISH ASPIRATION ON DILUTION REACTION TRAY WASH UNIT (DWUD) ASPIRATE NOZZLE 1, AND BACKFLUSHED IT. THEN, THE CSE VERIFIED SLUGGISH ASPIRATION ON DWUD ASPIRATE PORT 1, AND REPLACED NOZZLE, VALVE AND DWUD DILUTION WASH VALVE 1 (DWEV-01) ASPIRATE TUBING. THE CUSTOMER PERFORMED WASH 2 AND RAN QUALITY CONTROLS (QCS). THE CAUSE OF THE EVENT IS UNKNOWN. SIEMENS IS EVALUATING THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ERRONEOUS CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ADVIA 1800 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ORIGINAL ANALYZER. THE REPEAT RESULTS MATCHED PATIENT¿S CLINICAL HISTORY AND WERE CONSIDERED CORRECT. THE CUSTOMER DID NOT PROVIDE SAMPLE DATA TO SIEMENS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUS CO2_C RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720500 ADVIA 1800 ANALYZER ADVIA 1800 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 ANALYZER

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown