BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 1582908 · Received January 19, 2010

    Report

    Report Number
    1219913-2010-00005
    Event Type
    Other
    Date Received
    January 19, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 4, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE 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 UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A REPEATEDLY REACTIVE ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED ON A PT SAMPLE. THE PT SAMPLE WAS TESTED WITH THE ADVIA CENTAUR HBSAG CONFIRMATORY ASSAY AND THE RESULT WAS NOT CONFIRMED (NEGATIVE). THE CUSTOMER REPEATED TESTING FOR THE PT SAMPLE ON ANOTHER DATE AND THE RESULTS WERE NONREACTIVE (NEGATIVE). THE CUSTOMER MADE AN ALIQUOTE OF THE SAMPLE, RESPUN, AND TESTED ON THEIR OTHER INSTRUMENT. THE RESULTS WERE REACTIVE. IT IS UNK IF PT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) RESULT.

    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 145

    Patients

    Seq Age Sex Outcome Treatment
    1