BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY

    MDR report key: 2614777 · Received June 13, 2012

    Report

    Report Number
    1219913-2012-00237
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    April 30, 2012
    Report Date
    May 16, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P040004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH 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 UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. (B)(6) INFORMATION: ADVIA CENTAUR XP (B)(6) (AHBCM); (B)(6) CORE ANTIGEN, PRODUCT CODE: LOM; CATALOG #: 00504619; LOT #: UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). SIEMENS DATA INDICATES THAT THE OVERALL POSITIVE PERCENT AGREEMENT AND THE NEGATIVE PERCENT AGREEMENT REMAIN WITHIN THE 95% CONFIDENCE INTERVAL (CI) AS STATED IN THE PERFORMANCE CHARACTERISTICS SECTION OF THE HBC TOTAL INSTRUCTIONS FOR USE (IFU) DISTRIBUTED IN THE UNITED STATES.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP (B)(6) AND ADVIA CENTAUR XP (B)(6) RESULTS WERE OBTAINED FOR SAMPLES FROM THREE DIFFERENT PATIENTS. THE PHYSICIAN QUESTIONED THE RESULTS FOR PATIENTS 1 AND 2. THE PATIENT SAMPLES WERE SENT OUT FOR ADDITIONAL TESTING. THE RESULTS WERE NEGATIVE FOR PATIENTS 1 AND 2. THE RESULTS OF THE ADDITIONAL TESTING FOR PATIENT 3 WERE NOT PROVIDED BY THE CUSTOMER. THE PHYSICIAN REQUESTED A GASTROENTEROLOGY (GI) CONSULTATION FOR PATIENT 1. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) AND (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP HBC TOTAL (HBCT) ASSAY TOTAL ANTIBODY TO HEPATITIS B CORE (ANT-HBC TOTAL ASSAY) LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 044

    Patients

    Seq Age Sex Outcome Treatment
    1