BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 7266605 · Received February 13, 2018

    Report

    Report Number
    1219913-2018-00021
    Event Type
    Malfunction
    Date Received
    February 13, 2018
    Date of Event
    January 23, 2018
    Report Date
    August 2, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    UDI-DI
    00630414473161
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE TESTING OF THE RETURNED SAMPLE. IN HOUSE TESTING OBTAINED A (B)(6) RESULT (B)(6) WITH KIT LOT 062292. A SEPARATE WETCAKE TESTING WAS PERFORMED AND THE SAMPLE SHOWED (B)(6) REACTIVITY TO THE C200 ANTIGEN. THE SAMPLE WAS ALSO TESTED ON THE INNOLIA IMMUNOBLOT METHOD AND OVERALL INTERPRETATION WAS CONSIDERED INDETERMINATE. THESE RESULTS MATCHED THE CUSTOMERS IMMUNOBLOT METHOD WITH A (B)(6). SIEMENS ALSO RAN INTERNAL QUALITY CONTROL AS WELL AS QUALITY CONTROL PANELS AND ALL RESULTS RESULTED WITHIN RANGE. FURTHERMORE A PANEL OF 20 SEPARATE (B)(6) PATIENTS WAS RUN AND ALL SAMPLES RESULTED AS INTENDED. AT THIS TIME SIEMENS HAS CONFIRMED THE CUSTOMER'S OBSERVATION OF AN OVERALL (B)(6) RESPONSE ON THIS PATIENT SAMPLE. THE PATIENT IS NOT CURRENTLY ON ANY MEDICATION AND THE ONLY KNOWN INFORMATION IS THE PATIENT WAS (B)(6) IN THE PAST. THERE IS NO ROOT CAUSE THAT CAN BE DETERMINED AT THIS TIME. THIS MAY BE AN OLDER INFECTION WHERE THE TITERS OF THE ANTIBODIES HAVE FALLEN BELOW THE CUTOFF OF THE ASSAY. OVERALL EXPECTED SENSITIVITY FOR THE ADVIA CENTAUR HCV ASSAY IS 99.18-100% AS REFERENCED IN THE INSTRUCTIONS FOR USE (IFU) 10629876_EN REV Y, 2017-012. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00083 SUPPLEMENTAL REPORT 1 AND MDR 1219913-2018-00084 SUPPLEMENTAL REPORT 1 WERE FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE IFU STATES IN THE LIMITATIONS SECTION: "A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HCV. HCV ANTIBODIES MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS." MDR 1219913-2018-00083 AND MDR 1219913-2018-00084 WERE FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP HCV ((B)(6)) RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE PATIENT KNOWS HE HAS (B)(6). THE CUSTOMER PERFORMED TESTING WITH AN ALTERNATE METHOD FOR CONFIRMATION AND THE RESULT WAS (B)(6). THE (B)(6) RESULTS WERE NOT REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP HCV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109830 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 84112279 00630414473161

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR