BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 6241007 · Received January 11, 2017

    Report

    Report Number
    1219913-2016-00275
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 14, 2016
    Report Date
    April 11, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "A (B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00275 ON JANUARY 11, 2017. ON 03/21/2017 ADDITIONAL INFORMATION: SIEMENS RECEIVED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE PATIENT SAMPLE WAS TESTED ON THE ADVIA CENTAUR XP HCV LOTS 062270 AND 062271. THE RESULTS WERE (B)(6). SID (B)(6) , RESULTS: LOT 062270: (B)(6); LOT 062271: (B)(6). THE (B)(6) RESULTS ARE IN AGREEMENT WITH THE CUSTOMER'S OBSERVATION. SIEMENS IS UNABLE TO PROVIDE A CAUSE FOR THE (B)(6) RESULTS WITHOUT FURTHER CLINICAL HISTORY. SEVERAL REQUESTS WERE MADE TO GATHER ADDITIONAL INFORMATION FROM THE CUSTOMER BUT NO RESPONSE AT THIS TIME. THE CAUSE FOR THE DISCORDANT (B)(6) RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE (B)(6). THE (B)(6) RESULT ON THE PCR METHOD WAS VERY HIGH. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23388 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 264

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR