BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 1713298 · Received June 2, 2010

    Report

    Report Number
    1219913-2010-00064
    Event Type
    Other
    Date Received
    June 2, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 20, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE AND CONFIRMED USING THE ADVIA CENTAUR CONFIRMATORY ASSAY. THE PHYSICIAN QUESTIONED THE RESULT AND THE PT WAS REDRAWN. THE RESULT OF THE REDRAW WAS NON REACTIVE. THE NON REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE LABORATORY THEN DECIDED TO RETEST THE INITIAL SAMPLE. THE RESULTS WERE (B)(6). THE REDRAW SAMPLE WAS ALSO TESTED AGAIN ON TWO DIFFERENT INSTRUMENTS AND THE RESULTS WERE NON REACTIVE. 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 UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    A (B)(6) RESULT WAS OBTAINED FOR A PT SAMPLE AND CONFIRMED USING THE ADVIA CENTAUR CONFIRMATORY ASSAY. THE PHYSICIAN QUESTIONED THE RESULT AND THE PT WAS REDRAWN. THE RESULT OF THE REDRAW WAS NON REACTIVE. THE NON REACTIVE RESULT WAS REPORTED TO THE PHYSICIAN. THE LABORATORY THEN DECIDED TO RETEST THE INITIAL SAMPLE. THE RESULTS WERE (B)(6). THE REDRAW SAMPLE WAS ALSO TESTED AGAIN ON TWO DIFFERENT INSTRUMENTS AND THE RESULTS WERE NON REACTIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO (B)(6) RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1
    2