BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1321123 · Received February 20, 2009

    Report

    Report Number
    2432235-2009-00037
    Event Type
    Other
    Date Received
    February 20, 2009
    Date of Event
    December 10, 2008
    Report Date
    December 10, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT (B)(6) RESULTS WAS DUE TO THE CONTAMINATION OF THE WASH 1 BY THE INSTRUMENT OPERATOR, DURING THE DAILY CLEANING. THE INSTRUMENT WAS CLEANED, PRIMED, AND CALIBRATED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED ON A SECOND SYSTEM AND CORRECTED RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT (B)(6) RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT (B)(6) RESULTS WAS DUE TO THE CONTAMINATION OF THE WASH 1 BY THE INSTRUMENT OPERATOR, DURING THE DAILY CLEANING. THE INSTRUMENT WAS CLEANED, PRIMED, AND CALIBRATED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCREPANT ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED ON A SECOND SYSTEM AND CORRECTED RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT (B)(6) RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT (B)(6) RESULTS WAS DUE TO THE CONTAMINATION OF THE WASH 1 BY THE INSTRUMENT OPERATOR, DURING THE DAILY CLEANING. THE INSTRUMENT WAS CLEANED, PRIMED, AND CALIBRATED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    DISCREPANT ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED ON A SECOND SYSTEM AND CORRECTED RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT (B)(6) RESULTS.

    Additional Manufacturer Narrative · 4

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT (B)(6) RESULTS WAS DUE TO THE CONTAMINATION OF THE WASH 1 BY THE INSTRUMENT OPERATOR, DURING THE DAILY CLEANING. THE INSTRUMENT WAS CLEANED, PRIMED, AND CALIBRATED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 4

    DISCREPANT ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED ON A SECOND SYSTEM AND CORRECTED RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT (B)(6) RESULTS.

    Additional Manufacturer Narrative · 5

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT (B)(6) RESULTS WAS DUE TO THE CONTAMINATION OF THE WASH 1 BY THE INSTRUMENT OPERATOR, DURING THE DAILY CLEANING. THE INSTRUMENT WAS CLEANED, PRIMED, AND CALIBRATED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 5

    DISCREPANT ADVIA CENTAUR (B)(6) RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RETESTED ON A SECOND SYSTEM AND CORRECTED RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCREPANT (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY SYSTEM JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS ADVIA CENTAUR NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3
    4
    5