BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 3021855 · Received March 26, 2013

    Report

    Report Number
    1219913-2013-00054
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    November 16, 2012
    Report Date
    February 27, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULTS IS UNKNOWN. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE FIXED A POWER SUPPLY CONDUCTING PROBLEM AND CLEANED SYSTEM ASPIRATION PROBES, REAGENT PROBES AND WASH STATION. THE FSE FOUND NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULT. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED DISCORDANT PATIENT SAMPLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INFORMATION FOR USE (IFU) STATES IN THE LIMITATIONS SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS."

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2013: SIEMENS COMPLETED ITS INVESTIGATION ON THE TWO RETURNED SAMPLES. MULTI LOT TESTING WAS PERFORMED ON THE RETURNED SAMPLES. (B)(6). ON ADVIA CENTAUR LOT 062235, THE SAMPLE RESULT WAS EQUIVOCAL WITH AN INDEX OF (B)(6). SIEMENS WAS UNABLE TO CONFIRM THE NEGATIVE RESULTS OBTAINED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A FALSE NEGATIVE ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE (B)(6) TEST METHOD RESULTS AND PATIENT'S CLINICAL HISTORY. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6)RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124030 ADVIA CENTAUR XP HCV ASSAY HCV IMMUNOASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 232

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR