BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP HBSAG ASSAY

    MDR report key: 4103060 · Received September 19, 2014

    Report

    Report Number
    1219913-2014-00227
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 27, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE NON-REPRODUCIBLE ELEVATED ADVIA CENTAUR CP HBSAG RESULT IS UNKNOWN. THE CUSTOMER REPORTED THAT QC RESULTS WERE IN RANGE AND THAT THERE WERE NO OTHER HIGH HBSAG SAMPLE RESULTS THAT DAY. A SIEMENS SERVICE REPRESENTATIVE WENT ON SITE AND WENT OVER THE SYSTEM AND MAKE SOME CHANGES TO WASTE TUBING AND FITTINGS DUE TO DRIPPING FROM WASH AROUND AND ASPIRATE PROBES, NO OTHER PARTS CHANGED. NO CONCLUSIONS CAN BE DRAWN. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR HBSAG TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00227 ON AUGUST 27, 2014 REGARDING A NON-REPRODUCIBLE REACTIVE ADVIA CENTAUR CP HBSAG RESULT. OCTOBER 9, 2014 - ADDITIONAL INFORMATION. SERVICE WAS DISPATCHED TO CHECK THE INSTRUMENT. THE FIELD SERVICE ENGINEER REPLACED MULTIPLE PARTS INCLUDING THE LUMINOMETER, WASH BLOCK AND WASH STATION. POST SERVICE HBSAG PRECISION WAS VERIFIED AND QUALITY CONTROL MATERIAL WAS IN RANGE. THE CUSTOMER MONITORED THE ASSAY POST SERVICE AND IS SATISFIED WITH THE PERFORMANCE OF THE HBSAG ASSAY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED AN ADVIA CENTAUR CP HBSAG RESULT THAT WAS >1000 INDEX BUT WAS <0.1 INDEX UPON REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES BASED ON THE DISCORDANT ADVIA CENTAUR CP HBSAG RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581748 ADVIA CENTAUR CP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 063179

    Patients

    Seq Age Sex Outcome Treatment
    1