BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 1221829 · Received November 4, 2008

    Report

    Report Number
    1219913-2008-00088
    Event Type
    Other
    Date Received
    November 4, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 7, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    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 FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Additional Manufacturer Narrative · 3

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 3

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Additional Manufacturer Narrative · 4

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 4

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Additional Manufacturer Narrative · 5

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 5

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Additional Manufacturer Narrative · 6

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 6

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Additional Manufacturer Narrative · 7

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 7

    POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED ON SEVERAL PT SAMPLES. TWO RESULTS WERE REPORTED TO THE PHYSICIAN. THE PATIENTS HAD CARDIAC CATHETERIZATIONS PERFORMED AND THE RESULTS FOR BOTH WERE NEGATIVE. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 27

    Patients

    Seq Age Sex Outcome Treatment
    1 Other
    2
    3
    4
    5
    6
    7