BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 1122063 · Received August 14, 2008

    Report

    Report Number
    2432235-2008-00092
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 15, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULTS WAS DUE TO A MECHANICAL ISSUE WHERE THE SAMPLE RACK MOVEMENT WAS RESTRICTED THUS CAUSING THE SAMPLES TO BE MISMATCHED WITH THE RACK POSITION. 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

    DISCORDANT PT RESULTS FOR THE ADVIA CENTAUR TROPONIN, CKMB AND HCG ASSAYS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND CORRECTED REPORTS WERE ISSUED. THE DISCORDANT TROPONIN AND CK-MB RESULTS LED TO THE FOLLOWING PT INTERVENTION FOR ONE PT: TWO MEDICATIONS WERE GIVEN (BETA BLOCKER AND AN ACE INHIBITOR) ALONG WITH AN ELONGATED HOSP STAY (1 DAY). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULTS WAS DUE TO A MECHANICAL ISSUE WHERE THE SAMPLE RACK MOVEMENT WAS RESTRICTED THUS CAUSING THE SAMPLES TO BE MISMATCHED WITH THE RACK POSITION. 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

    DISCORDANT PT RESULTS FOR THE ADVIA CENTAUR TROPONIN, CKMB AND HCG ASSAYS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND CORRECTED REPORTS WERE ISSUED. THE DISCORDANT TROPONIN AND CK-MB RESULTS LED TO THE FOLLOWING PT INTERVENTION FOR ONE PT: TWO MEDICATIONS WERE GIVEN (BETA BLOCKER AND AN ACE INHIBITOR) ALONG WITH AN ELONGATED HOSP STAY (1 DAY). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Additional Manufacturer Narrative · 3

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULTS WAS DUE TO A MECHANICAL ISSUE WHERE THE SAMPLE RACK MOVEMENT WAS RESTRICTED THUS CAUSING THE SAMPLES TO BE MISMATCHED WITH THE RACK POSITION. 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

    DISCORDANT PT RESULTS FOR THE ADVIA CENTAUR TROPONIN, CKMB AND HCG ASSAYS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND CORRECTED REPORTS WERE ISSUED. THE DISCORDANT TROPONIN AND CK-MB RESULTS LED TO THE FOLLOWING PT INTERVENTION FOR ONE PT: TWO MEDICATIONS WERE GIVEN (BETA BLOCKER AND AN ACE INHIBITOR) ALONG WITH AN ELONGATED HOSP STAY (1 DAY). THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3