BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2133033 · Received June 17, 2011

    Report

    Report Number
    2432235-2011-00086
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT CALCIUM AND CO2 RESULTS WAS A LEAK IN THE SAMPLING PUMP SEALS. THE FSE REPLACED THE SAMPLING PUMP SEALS AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT RESULT WAS OBTAINED FOR CALCIUM AND CO2 FOR ONE PATIENT SAMPLE ON AN ADVIA 1800 SYSTEM. THE SAMPLE WAS RE-TESTED ON THE SAME ANALYZER AND NORMAL RESULTS WERE OBTAINED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CALCIUM AND CO2 RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1