BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 12063258 · Received June 24, 2021

    Report

    Report Number
    2432235-2021-00150
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 24, 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 A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED A DISCORDANT, FALSELY DEPRESSED CONCENTRATED CARBON DIOXIDE (CO2_C) RESULT FOR ONE PATIENT WAS OBTAINED ON AN ADVIA 1800 INSTRUMENT. THE CUSTOMER REPORTED THAT THE QUALITY CONTROLS (QC) WERE IN RANGE PRIOR TO PROCESSING THE SAMPLE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER'S SITE MULTIPLE TIMES AND THE CSE REPLACED THE MIXER 1 BELT AND LARGE WATER PUMP (LWP), PERFORMED MULTIPLE SYSTEM PRIMES, RAN THREE WASH 2 CYCLES, AND CLEANED AND LUBRICATED THE MIXER 1 LINEAR GUIDE AND ECCENTRIC BUSHING. THEN, THE CSE CHECKED MIXER BELT TENSION AND MIXER POSITIONING IN REACTION TRAY (RRV) CUVETTES WHICH WERE ACCEPTABLE. THE CSE CONFIRMED THAT THE MIXER MOTOR WAS FUNCTIONING PROPERLY. SIEMENS FOLLOWED UP WITH THE CUSTOMER AND THEY INDICATED THAT THE INSTRUMENT IS OPERATIONAL. SIEMENS FURTHER INVESTIGATED THE ISSUE AND CONCLUDED THAT THIS IS NOT A REAGENT LOT OR METHOD ISSUE. THE SAMPLE DESCRIBED ABOVE WAS THE ONLY AFFECTED SAMPLE AND NO OTHER DISCORDANT RESULTS WERE OBTAINED. THE CAUSE FOR THE FALSELY DEPRESSED CO2_C PATIENT RESULT WAS THE INSTRUMENT. THE DEVICE 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 FOR ONE PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE FALSELY DEPRESSED RESULT FAILED THE DELTA CHECK AND WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPROCESSED ON AN ALTERNATE ADVIA 1800 INSTRUMENT AND RESULTED HIGHER THAN THE INITIAL RESULT AND WAS WITHIN DELTA CHECK. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CO2_C PATIENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955125 ADVIA 1800 ADVIA 1800 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 00630414534794

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR