BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 1014027 · Received March 14, 2008

    Report

    Report Number
    2432235-2008-00007
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    January 20, 2008
    Report Date
    January 21, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE HIGH VALUES REPORTED ON PATIENT SAMPLES AND QC VALUES WERE DUE TO THE EMPTY WASH 1 RESERVOIR. A SIEMENS HEALTHCARE DIAGNOSTICS INC FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE ACCOUNT AND CORRECTED THE MALFUNCTION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    SEVERAL FALSELY ELEVATED TROPONIN I RESULTS WERE OBTAINED ON A PATIENTS' SAMPLES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE ORIGINAL SAMPLES WERE RETESTED AND NEGATIVE RESULTS WERE OBTAINED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED TROPONIN I RESULTS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE HIGH VALUES REPORTED ON PATIENT SAMPLES, AND QC VALUES WERE DUE TO THE EMPTY WASH 1 RESERVOIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNO-ASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS MFG LTD NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1