BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP FOLATE (FOL) ASSAY

    MDR report key: 3943731 · Received July 18, 2014

    Report

    Report Number
    1219913-2014-00185
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CGN
    PMA / PMN Number
    K010050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIALLY FALSE HIGH (> 24) ADVIA CENTAUR XP FOLATE RED BLOOD CELL (RBC) RESULTS OBSERVED BY THE CUSTOMER ON THE PATIENT'S RBC HEMOLYSATE TEST SAMPLE IS UNKNOWN. PREVENTATIVE MAINTENANCE WAS COMPLETED ON BOTH ADVIA CENTAUR SYSTEMS AND THE CUSTOMER'S SYSTEM MAINTENANCE WAS ACCEPTABLE. THE CUSTOMER PERFORMED AN RBC HEMOLYSATE AUTO DILUTION WHEN THE INITIAL RESULT WAS OVER-RANGE, HOWEVER THIS IS CONSIDERED A USE ERROR. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING UNDER THE PROCEDURAL NOTES FOR DILUTION AND PREPARING THE RED BLOOD CELL HEMOLYSATE: "DO NOT DILUTE THE RBC HEMOLYSATE." THE ADVIA CENTAUR SYSTEMS ARE PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    FALSELY HIGH ADVIA CENTAUR XP FOLATE RED BLOOD CELL (RBC) RESULTS WERE OBSERVED BY THE CUSTOMER ON A PATIENT SAMPLE. THE INITIAL TEST RESULT ON THE RBC HEMOLYSATE SAMPLE WAS OVER-RANGE AND THE AUTO DILUTION RESULT WAS HIGH, HOWEVER, ON REPEAT THE TEST RESULTS WERE WITHIN RANGE LIMITS. THE CUSTOMER RAN THE PATIENT SAMPLE ON ANOTHER ADVIA CENTAUR SYSTEM AND OBSERVED SIMILAR FOLATE RED BLOOD CELL (RBC) RESULTS. A NEW RBC HEMOLYSATE SAMPLE WAS PREPARED DUE TO THE FALSE HIGH TEST RESULTS AND RUN ON BOTH ADVIA CENTAUR SYSTEMS. THE NEW HEMOLYSATE SAMPLE TEST RESULTS WERE LOWER. THERE ARE NO KNOWN REPORTS OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH ADVIA CENTAUR XP FOLATE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421939 ADVIA CENTAUR XP FOLATE (FOL) ASSAY FOLATE IMMUNOASSAY, PRODUCT CODE: CGN SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 071227

    Patients

    Seq Age Sex Outcome Treatment
    1