BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 4093261 · Received September 16, 2014

    Report

    Report Number
    1219913-2014-00225
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 18, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP (B)(4) RESULT IS UNKNOWN. SIEMENS SERVICE WENT ON SITE AND PERFORMED A TOTAL SERVICE CALL. CHECKED THAT THE DISPENSES AND ASPIRATION FROM THE WASH BLOCK WERE ALL GOOD. CHECKED FOR BLEACH CONTAMINATION AND FOUND NONE. VERIFIED DARK COUNTS WERE GOOD. CHECKED THAT ACID AND BASE DISPENSES WERE GOOD. VERIFIED VACUUM PRESSURE WAS GOOD. VERIFIED PROBE ALIGNMENTS. VERIFIED THAT THERE WERE NO LEAKS IN THE WASH MANIFOLD AREA. FOUND A LARGE AMOUNT OF SERUM AND REAGENT CRUSTED AROUND THE ENTRY PORTS FOR SAMPLE AND ANCILLARY PROBES. THE AREA WAS CLEANED AND AN EMPTY/FILL OF CUVETTES WAS PERFORMED. QUALITY CONTROL MATERIAL WAS RUN AND SYSTEM WAS FOUND TO BE OPERATION. NO CONCLUSIONS CAN BE DRAWN. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR (B)(4) 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

    CUSTOMER OBSERVED AN (B)(6) RESULT OF (B)(6). CONFIRMATION TESTING WAS INVALID AND REPEAT TESTING OF THE SAME SAMPLE WAS (B)(6). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES BASED ON THE INITIALLY (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571122 ADVIA CENTAUR XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 063180

    Patients

    Seq Age Sex Outcome Treatment
    1