BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HBSAG ASSAY

    MDR report key: 3120561 · Received May 20, 2013

    Report

    Report Number
    1219913-2013-00102
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) ADVIA CENTAUR (B)(6) RESULT WHEN COMPARED TO THE NON REACTIVE TEST RESULT FROM AN ALTERNATE LABORATORY IS UNKNOWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WAS ACCEPTABLE AT THE TIME OF THE EVENT. THE DISCORDANT PATIENT SAMPLE IS NOT AVAILABLE FOR FURTHER INVESTIGATION AND THE CUSTOMER HAS DECLINED A FIELD SERVICE VISIT. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A (B)(4) ADVIA CENTAUR (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO AN ALTERNATE LABORATORY NON REACTIVE (B)(6) DNA RESULT. THE CUSTOMER HAD SENT THE PATIENT SAMPLE TO THE ALTERNATE LABORATORY FOR CONFIRMATION TESTING. THE NON REACTIVE (B)(6) TEST RESULT WAS REPORTED TO THE PHYSICIAN. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE ADVIA CENTAUR HBSAG ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222764 ADVIA CENTAUR HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 170

    Patients

    Seq Age Sex Outcome Treatment
    1