BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 1734281 · Received June 21, 2010

    Report

    Report Number
    1219913-2010-00070
    Event Type
    Other
    Date Received
    June 21, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 7, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (B)(6) RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) RESULTS WERE OBTAINED FOR TWO PATIENTS SAMPLES. THE LABORATORY'S POLICY IS TO REPEAT ALL HIGH RESULTS. THE PATIENTS SAMPLES WERE REPEATED AND THE RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULTS.

    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 (B)(6) RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    (B)(6) RESULTS WERE OBTAINED FOR TWO PATIENTS SAMPLES. THE LABORATORY'S POLICY IS TO REPEAT ALL HIGH RESULTS. THE PATIENTS SAMPLES WERE REPEATED AND THE RESULTS WERE NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 148

    Patients

    Seq Age Sex Outcome Treatment
    1
    2