BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1366360 · Received April 20, 2009

    Report

    Report Number
    2432235-2009-00082
    Event Type
    Other
    Date Received
    April 20, 2009
    Date of Event
    March 26, 2009
    Report Date
    March 31, 2009
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE DISCREPANT HCV RESULTS WERE DUE TO THE CUSTOMER NOT USING THE RECOMMENDED SAMPLE TUBE TYPES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT CENTAUR XP HCV RESULTS WERE OBTAINED ON PT SAMPLES. THE DISCREPANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED AND THE CORRECT RESULTS WERE REPORTED. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE DISCREPANT HCV RESULTS WERE DUE TO THE CUSTOMER NOT USING THE RECOMMENDED SAMPLE TUBE TYPES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCREPANT CENTAUR XP HCV RESULTS WERE OBTAINED ON PT SAMPLES. THE DISCREPANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED AND THE CORRECT RESULTS WERE REPORTED. THERE ARE NO REPORTS OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNO-ASSAY ANALYZER JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2