BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 12214597 · Received July 22, 2021

    Report

    Report Number
    2432235-2021-00189
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 28, 2021
    Report Date
    July 22, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    UDI-DI
    00630414534794
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER INDICATED THAT THERE HAVE NOT BEEN SYSTEM ERRORS AND QUALITY CONTROLS (QC) RECOVERED WITHIN ACCEPTABLE RANGES. A CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE VERIFIED THAT THE VACUUM ON BOTH SIDES OF THE PUMP WAS WORKING; THERE WAS GOOD WATER SUPPLY PUMP (LWP) PRESSURE AND ALL NOZZLES WERE CLEAR. THE CSE REPLACED BOTH SYSTEM CHECK VALVES ON INPUT SALINE AND WATER LINES TO PUMPS AND REPLACED KINKED TUBING BETWEEN THE CHECK VALVE AND THE SAMPLE REAGENT WASH PUMP (SRWP) AS IT WAS TOO SHORT CAUSING TUBING TO FOLD AT CONNECTIONS. THE CSE ALSO DETERMINED THAT REACTION TRAY WASH UNIT (WUD) AND DILUTION TRAY WASH UNIT (DWUD) WATER VALVES WERE OPERATING PROPERLY, AND VERIFIED THAT THE PROBES WERE CORRECTLY POSITIONED. THE POSITION FROM THE DILUTION PROBE PIPETTE (DPP) PROBE TO THE APTIO ASPIRATE WAS MISALIGNED BECAUSE THE TUBE WAS MISPOSITIONED. THE CSE PRIMED THE PUMP MULTIPLE TIMES AND VERIFIED THAT THE MIXER POSITION WAS ACCEPTABLE. THEY REMOVED THE PANELS AND ADJUSTED THE DPP ARM SINCE IT WAS BIASED TO THE FRONT OF THE INSTRUMENT. THE CSE ALSO REPLACED A COOLING FAN ON THE CHILLER DOOR. AFTER MOVING THE PROBE MORE TO THE CENTER NO ADDITIONAL ISSUES WERE OBSERVED. THEY MONITORED THE INSTRUMENT AND READJUSTED ALL OTHER DILUTION PROBE PIPETTE (DPP) PROBE POSITIONS AND RAN WASH 3. THE CAUSE OF THE EVENT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S) AS IT WAS FLAGGED AS CRITICAL. THE SAMPLE WAS REPEATED ON AN ALTERNATE ADVIA 1800 INSTRUMENT. THE REPEAT RESULT WAS HIGHER THAN THE DISCORDANT RESULT. THE REPEAT RESULT WAS REPORTED AS THE CORRECT RESULT, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CO2_C RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108488 ADVIA 1800 ADVIA 1800 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC ADVIA 1800 00630414534794

    Patients

    Seq Age Sex Outcome Treatment
    1