BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 1742974 · Received June 28, 2010

    Report

    Report Number
    1219913-2010-00074
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    May 27, 2010
    Report Date
    June 10, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    MZP
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A NON REACTIVE ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED ON A PT SAMPLE. VIRAL LOAD TESTING WAS ALSO PERFORMED AND THE RESULT WAS (B)(6). THE PHYSICIAN QUESTIONED THE RESULTS. THE PT WAS REDRAWN AND TESTED ON THE ADVIA CENTAUR XP. THE RESULT WAS NON REACTIVE. VIRAL LOAD TESTING WAS REPEATED AND THE RESULT WAS (B)(6). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NON REACTIVE ADVIA CENTAUR XP (B)(6) 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 (B)(6) RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    A (B)(6) RESULT WAS OBTAINED ON A PT SAMPLE. VIRAL LOAD TESTING WAS ALSO PERFORMED AND THE RESULT WAS (B)(6). THE PHYSICIAN QUESTIONED THE RESULTS. THE PT WAS REDRAWN AND TESTED ON THE ADVIA CENTAUR XP. THE RESULT WAS NON REACTIVE. VIRAL LOAD TESTING WAS REPEATED AND THE RESULT WAS (B)(6). PT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NON REACTIVE ADVIA CENTAUR XP (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZP SIEMENS HEALTHCARE DIAGNOSTICS INC NA 217

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR
    2 34 YR