BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3383631 · Received October 3, 2013

    Report

    Report Number
    2432235-2013-00466
    Event Type
    Malfunction
    Date Received
    October 3, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 1, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS GLOBAL PRODUCT SUPPORT (GPS) SPECIALIST EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE CHLORIDE ELECTRODES THAT HAD BEEN USED BY THE CUSTOMER SHOULD BE TESTED BY SIEMENS HEALTHCARE DIAGNOSTICS. THE CUSTOMER RETURNED FIVE CHLORIDE ELECTRODES TO SIEMENS HEALTHCARE DIAGNOSTICS, AND THE GPS DEPARTMENT TESTED THEM. THE CALIBRATION PASSED FOR EACH ELECTRODE AND QUALITY CONTROLS WERE WITHIN RANGE FOR FOUR OF THE FIVE ELECTRODES. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED CHLORIDE RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2013-00466 WAS FILED ON OCTOBER 3, 2013. ADDITIONAL INFORMATION (09/02/2014): SIEMENS HEALTHCARE DIAGNOSTICS, INC. PERFORMED A STUDY OF ION SELECTIVE ELECTRODE (ISE) USAGE, WHICH SHOWS THAT THERE HAS NOT BEEN AN INCREASE IN USAGE. A SYSTEMIC PROBLEM WITH THE ELECTRODES WOULD MANIFEST WITH HIGHER THAN EXPECTED ELECTRODE USAGE. THIS PRODUCT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED CHLORIDE RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND RESULTED LOWER. IT IS UNKNOWN IF THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CHLORIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501260 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1