BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3841911 · Received May 30, 2014

    Report

    Report Number
    2432235-2014-00351
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA. AFTER INSTRUMENT EVALUATION, THE CSE DETERMINED THAT THE DELIVERY OF BUFFER AND BUFFER/SAMPLE MIXTURE THROUGH THE ELECTRODE WAS COMPROMISED. THE CSE ALSO DETERMINED THAT THE ION SELECTIVE ELECTRODE (ISE) PUMP SEALS REQUIRED REPLACEMENT. THE CAUSE OF THE DISCORDANT CHLORIDE RESULTS WAS DUE TO WORN ISE PUMP SEALS. THE CSE REPLACED THE ISE PUMP SEALS, PERFORMED INSTRUMENT CALIBRATION AND SUCCESSFULLY RAN PRECISION AND QC. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED CHLORIDE RESULTS WERE OBTAINED ON FOUR PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT CHLORIDE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE SYSTEM AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CHLORIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318775 ADVIA 1800 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1