BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 1160506 · Received September 11, 2008

    Report

    Report Number
    2432235-2008-00100
    Event Type
    Other
    Date Received
    September 11, 2008
    Date of Event
    August 17, 2008
    Report Date
    August 28, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT INDICATES THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT WAS DUE TO A BUILD UP ON THE STEM OF THE SAMPLE SYRINGE. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THREE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE GENERATED IN THE LAB AND WERE NOT REPORTED TO THE PHYSICIAN. UPON RE-TEST THE TROPONIN ULTRA RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT INDICATES THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT WAS DUE TO A BUILD UP ON THE STEM OF THE SAMPLE SYRINGE. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    THREE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE GENERATED IN THE LAB AND WERE NOT REPORTED TO THE PHYSICIAN. UPON RE-TEST, THE TROPONIN ULTRA RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT INDICATES THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT WAS DUE TO A BUILD UP ON THE STEM OF THE SAMPLE SYRINGE. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    THREE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE GENERATED IN THE LAB AND WERE NOT REPORTED TO THE PHYSICIAN. UPON RE-TEST THE TROPONIN ULTRA RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP IMMUNO-ASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3