BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 7148151 · Received December 27, 2017

    Report

    Report Number
    1219913-2017-00259
    Event Type
    Malfunction
    Date Received
    December 27, 2017
    Date of Event
    December 12, 2017
    Report Date
    August 3, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00259 ON DECEMBER 27, 2017. 06/08/2018 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS TESTED IN-HOUSE. SIEMENS WAS ABLE TO REPRODUCE THE CUSTOMER'S FINDING OF A NEGATIVE RESULT ON THE HCV ASSAY. INNOLIA WAS ALSO PERFORMED BUT WAS POSITIVE INDICATING THERE WAS PAST INFECTION. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE. ADDITIONAL TESTING WILL BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) RESULT 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00259 ON DECEMBER 27, 2017. SIEMENS FILED THE MDR 1219913-2017-00259 SUPPLEMENTAL REPORT 1 ON JUNE 28, 2018. ON 07/30/2018 ADDITIONAL INFORMATION: SIEMENS HAS COMPLETED THE TESTING OF THE RETURNED SAMPLE. IN HOUSE TESTING OBTAINED A NEGATIVE RESULT (INDEX OF 0.731) WITH KIT LOT 062292. A SEPARATE WETCAKE TESTING WAS PERFORMED AND THE SAMPLE SHOWED LOW REACTIVITY TO THE C200 ANTIGEN. THE SAMPLE WAS ALSO TESTED ON THE INNOLIA IMMUNOBLOT METHOD AND OVERALL INTERPRETATION WAS CONSIDERED NEGATIVE. SIEMENS ALSO RAN INTERNAL QUALITY CONTROL AS WELL AS QUALITY CONTROL PANELS AND ALL RESULTS RESULTED WITHIN RANGE. FURTHERMORE A PANEL OF 20 SEPARATE NEGATIVE PATIENTS WAS RUN AND ALL SAMPLES RESULTED AS INTENDED. AT THIS TIME SIEMENS HAS CONFIRMED THE CUSTOMER OBSERVATION OF AN OVERALL NEGATIVE RESPONSE ON THIS PATIENT SAMPLE. SIEMENS HAD REQUESTED OF FURTHER MEDICAL TREATMENT AND TESTING RESULTS IN THE PAST AND HAS BEEN ADVISED THAT THE INFORMATION IS NOT AVAILABLE INCLUDING COPIES OF THE PCR REPORT. THERE IS NO ROOT CAUSE THAT CAN BE DETERMINED AT THIS TIME. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HCV (AHCV) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE PCR AND BLOT RESULTS WERE (B)(6) FOR (B)(6). THE PATIENT SAMPLE WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS (B)(6). THE PATIENT IS A (B)(6) CONFIRMED DIALYSE PATIENT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP HCV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927088 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 279 00630414473161

    Patients

    Seq Age Sex Outcome Treatment
    1