BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 12010242 · Received June 16, 2021

    Report

    Report Number
    2432235-2021-00148
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 26, 2021
    Report Date
    June 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
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 2432235-2021-00148 ON 16-JUN-2021. CORRECTION (17-JUN-2021): IN THE PREVIOUS MDR, THE "TYPE OF INVESTIGATION" CODE IN SECTION H6 WAS INADVERTENTLY DOCUMENTED AS "4118", WHICH SIGNIFIES TYPE OF INVESTIGATION NOT YET DETERMINED. AS INDICATED IN THE INITIAL MDR, A SIEMENS CUSTOMER SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER'S SITE TO INSPECT THE INSTRUMENT. THE "TYPE OF INVESTIGATION" CODE SHOULD HAVE BEEN "10", WHICH CORRELATES TO TESTING OF ACTUAL/SUSPECTED DEVICE. THE "TYPE OF INVESTIGATION" CODE IN SECTION H6 WAS UPDATED TO REFLECT THE CORRECTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER AND REPORTED THAT A DISCORDANT, ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON THE ADVIA 1800 INSTRUMENT. QUALITY CONTROLS (QC) WERE WITHIN ACCEPTABLE RANGES ON THE DAY OF THE EVENT. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE CSE INSPECTED THE REACTION TRAY WASH UNIT (WUD) AND DILUTION REACTION TRAY WASH UNIT (DWUD) AND DID NOT SEE A LEAK. ADDITIONALLY, THE VACUUM WAS UNBLOCKED AND THE LARGE WATER PUMP (LWP) WAS TURNED ON AND PRESSURE WAS INCREASED TWICE, AND NO LEAK WAS FOUND. THEN, THE CSE RAN APPROXIMATELY 60 CO2_C TESTS WITH ACCURATE RECOVERY. NEXT, THE CSE PERFORMED A WASH. AS PER THE CUSTOMER'S REQUEST, THE CSE REPLACED THE REACTION TRAY WASH UNIT DRAIN VALVE 3, REACTION TRAY WASH UNIT DRAIN VALVE 2, AND CHECK VALVE, PRIMED THE INSTRUMENT, AND RAN QC, WHICH RECOVERED ACCEPTABLY. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE ALTERNATE ADVIA CHEMISTRY INSTRUMENT AND LOWER RESULTS WERE OBTAINED. THE REPEAT RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903659 ADVIA 1800 ADVIA 1800 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 00630414534794

    Patients

    Seq Age Sex Outcome Treatment
    1