BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR HCV (AHCV) ASSAY

    MDR report key: 3692405 · Received March 21, 2014

    Report

    Report Number
    1219913-2014-00073
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) PATIENT RESULT COMPARED TO (B)(6) TEST RESULTS FROM TWO OTHER ALTERNATE HCV TEST METHODS AND HEPATOLOGY TESTS IS UNKNOWN. THE HCV QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE LIMITS AT THE TIME OF THE EVENT. SIEMENS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE IFU STATES IN THE LIMITATIONS SECTION: "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A (B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO (B)(6)."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00073 ON 03/21/2014 FOR A (B)(6) PATIENT RESULT WHEN COMPARED TO ALTERNATE HCV TEST METHODS. ON 05/19/2014 - THE PATIENT SAMPLE WAS PROVIDED FOR FURTHER INVESTIGATION. SIEMENS INVESTIGATION RESULTS: THE TEST RESULTS WERE (B)(6) IN TWO HCV REAGENT LOTS: 062242 ((B)(6)) AND 062246 ((B)(6)) AND EQUIVOCAL IN LOT 062243 ((B)(6)). ACCORDING TO THE IFU WITH ONE EQUIVOCAL AND TWO (B)(6), THIS SAMPLE IS CONSIDERED (B)(6). THIS IS THE SAME OBSERVATION BY THE CUSTOMER WHOSE TEST RESULTS WERE (B)(6) IN TWO HCV REAGENT LOTS: 062240 (0.74) AND 062243 (0.64 AND 0.79). THE INNO-LIA HCV SCORE WESTERN BLOT RESULTED IN A (B)(6). BASED ON SIEMENS INTERNAL TEST RESULTS, THIS IS NOT CONSIDERED A SITE ISSUE OR LOT SPECIFIC ISSUE AND THE ASSAY IS MEETING IFU SENSITIVITY CLAIMS. THE CAUSE FOR THE FALSE NEGATIVE ADVIA CENTAUR XP HCV PATIENT RESULTS COMPARED TO THE ALTERNATE HCV TEST METHOD IS UNKNOWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING UNDER 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." "ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR HCV ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HCV SEROLOGICAL MARKERS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00073 ON 03/21/2014 FOR A FALSE NEGATIVE (B)(6) PATIENT RESULT WHEN COMPARED TO ALTERNATE (B)(6) TEST METHODS AND MDR SUPPLEMENTAL REPORT 1 ON 05/28/2014 FOR ADDITIONAL TEST INFORMATION. 06/26/2014 - ADDITIONAL TEST INFORMATION: SIEMENS PERFORMED PCR TESTING ON THE RETURNED PATIENT SAMPLE AND THERE WAS NO (B)(6) RNA DETECTED INDICATING THAT THE PATIENT IS NOT CURRENTLY INFECTED WITH (B)(6). SIEMENS INVESTIGATION RESULT: TEST NAME: (B)(6) RNA QUALITATIVE (TMA), RESULT: NOT DETECTED. THE CAUSE FOR THE NEGATIVE ADVIA CENTAUR XP (B)(6) PATIENT RESULT COMPARED TO THE ALTERNATE (B)(6) TEST METHODS IS UNKNOWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING UNDER THE LIMITATIONS SECTION: "A NEGATIVE 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." "ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED WHEN THE ADVIA CENTAUR (B)(6) ASSAY IS USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC (B)(6) SEROLOGICAL MARKERS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO (B)(6) TEST RESULTS FROM TWO OTHER ALTERNATE HCV TEST METHODS AND HEPATOLOGY TESTS. THE PATIENT INITIALLY TESTED (B)(6) WHEN TESTED AT ALTERNATE LABORATORY AND HCV TEST METHOD. THE PATIENT SAMPLE WAS SENT TO THIS CUSTOMER SITE FOR VERIFICATION TESTING ON THE ADVIA CENTAUR XP HCV TEST METHOD AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS SENT TO SECOND ALTERNATE LABORATORY WITH ANOTHER HCV TEST METHOD AND THE RESULT WAS POSITIVE. THE PATIENT WAS REDRAWN ON TWO SEPARATE DATES AND THE ADVIA CENTAUR XP HCV RESULTS WERE BOTH NEGATIVE WHEN TESTED WITH A NEW HCV REAGENT LOT. THE REDRAWN PATIENT SAMPLES WERE (B)(6) ON THE TWO ALTERNATE HCV TEST METHODS. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170308 ADVIA CENTAUR HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY, MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062240, 062243

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR