BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP HBSAG ASSAY

    MDR report key: 3902845 · Received June 30, 2014

    Report

    Report Number
    1219913-2014-00159
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    May 26, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE FOUND THE WASTE TUBING HAD BEEN FOLDED AND THE WASTE FLUID OVERFLOWED BACK FROM THE REAGENT PROBE DRAIN. THIS WAS FIXED. THE FSE DECONTAMINATED THE WATER AND WASTE RESERVOIRS. THE CAUSE FOR THE (B)(6) RESULT IS POSSIBLE REAGENT PROBE CONTAMINATION. THERE WERE NO OTHER DISCORDANT RESULTS IDENTIFIED IN THE SAME RUN. THE REAGENT WAS FULLY SUSPENDED. THE PATIENT SAMPLE IS UNAVAILABLE FOR FURTHER INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INFORMATION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR (B)(6) TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. REPEAT TESTING WAS PERFORMED AND THE RESULT WAS (B)(6). THE INITIAL (B)(6) RESULT WAS NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379361 ADVIA CENTAUR CP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 175

    Patients

    Seq Age Sex Outcome Treatment
    1