BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 2960634 · Received February 14, 2013

    Report

    Report Number
    1219913-2013-00023
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT IS UNKNOWN. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND FOUND NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT (B)(6) RESULT. QUALITY CONTROL RESULTS WERE WITHIN RANGE. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE INFORMATION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "RESULTS SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND WAS CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT TESTING PERFORMED ON AN ALTERNATE ADVIA CENTAUR SYSTEM. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65030 ADVIA CENTAUR HBSAG ASSAY HBSAG IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 169

    Patients

    Seq Age Sex Outcome Treatment
    1