BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1800

    MDR report key: 2042718 · Received April 6, 2011

    Report

    Report Number
    2432235-2011-00045
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 9, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER SITE. THE CUSTOMER STATED THE NA ELECTRODE HAD BEEN ON THE ADVIA 1800 FOR 3 AND 1/2 MONTHS WHEN THE DISCORDANT RESULT OCCURRED. THE FSE HAD THE CUSTOMER REPLACE THE SODIUM ELECTRODE AND RUN QC. PER SIEMENS PRODUCT LABELING, THE SODIUM ELECTRODE IS WARRANTED UP TO 30,000 SAMPLES, FOR 3 MONTHS FROM THE TIME THE ELECTRODE WAS PLACED ON THE SYSTEM OR UNTIL THE EXPIRATION DATE STAMPED ON THE ELECTRODE BOX, WHICHEVER OCCURS FIRST. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA 1800 SODIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. REPEAT TESTING WAS PERFORMED ON ANOTHER ADVIA 1800 SYSTEM AND THE CORRECTED RESULT WAS REPORTED. THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALAYZER, PRODUCT CODE: JJE SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1