BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV ASSAY

    MDR report key: 3140624 · Received May 31, 2013

    Report

    Report Number
    1219913-2013-00126
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) PATIENT RESULT ON THE ADVIA CENTAUR XP SYSTEM WHEN COMPARED TO THE (B)(6) TEST METHOD RESULT THAT WAS CONFIRMED (B)(6) TEST METHOD IS UNKNOWN. THE CUSTOMER PERFORMED ADDITIONAL (B)(6) TESTING AND THE RESULT WAS NEGATIVE INDICATING NO ACTIVE (B)(6) INFECTION. A SIEMENS FIELD APPLICATION SPECIALIST (FAS) WAS ONSITE FOR FURTHER INVESTIGATION AND PERFORMED AN ASSAY CALIBRATION AND QUALITY CONTROL RUN. THE ASSAY CALIBRATION WAS VALID AND THE QUALITY CONTROL RESULTS WERE ACCEPTABLE. THE PATIENT SAMPLE WAS RUN MULTIPLE TIMES AFTER CALIBRATION AND PASSING QUALITY CONTROL AND THE RESULTS WERE ALL NEGATIVE. THERE WERE NO OTHER (B)(6) PATIENT RESULTS REPORTED BY THE CUSTOMER AT THE TIME THAT THIS EVENT OCCURRED. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING IN THE LIMITATION 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." SIEMENS FAS TEST RESULTS: (B)(6).

    Description of Event or Problem · 1

    A (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO ALTERNATE HCV TEST METHOD POSITIVE RESULT. AFTER THE INITIAL (B)(6) TEST RESULT THE CUSTOMER PERFORMED REPEAT (B)(6) TESTING ON AN ALTERNATE (B)(6) TEST METHOD AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS REPEATED ON THE ADVIA CENTAUR XP THE NEXT DAY AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS RERUN AFTER CENTRIFUGATION AND THE RESULT WAS NEGATIVE. THE PATIENT SAMPLE WAS SENT OUT FOR CONFIRMATION TESTING ON A SECOND ALTERNATE (B)(6) TEST METHOD AND THE RESULT WAS CONFIRMED AS (B)(6). DUE TO THE DIFFERENCE IN THE ALTERNATE TEST METHOD RESULTS, THE CUSTOMER PERFORMED (B)(6) TESTING ON THE PATIENT SAMPLE AND THE RESULT WAS NEGATIVE INDICATING NO ACTIVE INFECTION. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE NEGATIVE ADVIA CENTAUR XP (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242252 ADVIA CENTAUR XP HCV ASSAY HEPATITIS C VIRUS (ANTI-HCV) MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 236

    Patients

    Seq Age Sex Outcome Treatment
    1