BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV) ASSAY

    MDR report key: 6679184 · Received June 29, 2017

    Report

    Report Number
    1219913-2017-00144
    Event Type
    Malfunction
    Date Received
    June 29, 2017
    Date of Event
    June 3, 2017
    Report Date
    July 24, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    UDI-DI
    00630414473161
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00144 ON 06/29/2017 FOR A FALSE NON-REACTIVE ADVIA CENTAUR XP HCV (AHCV) PATIENT RESULT. 07/05/2017 - ADDITIONAL INFORMATION: A RIBA TEST WAS PERFORMED BY THE CUSTOMER AND THE RESULT WAS POSITIVE. A THIN BAND, CONSIDERED POSITIVE FOR ANTIBODIES. THERE IS INSUFFICIENT PATIENT SAMPLE AVAILABLE FOR TESTING BY SIEMENS. THE CAUSE FOR THE FALSE NEGATIVE ADVIA CENTAUR XP AHCV RESULT IS UNKNOWN. BASED ON A POSITIVE RIBA, AND INNO-LIA , THIS PATIENT SHOULD HAVE BEEN POSITIVE FOR HCV, HOWEVER IF THE PATIENT HAS SUCCESSFULLY CLEARED THE HCV VIRUS, AND THERE HAS BEEN A SIGNIFICANT AMOUNT OF TIME, IT IS POSSIBLE THAT THE LEVEL OF ANTIBODY HAS FALLEN BELOW THE CUTOFF. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (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. 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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULT COMPARED TO (B)(6) ALTERNATE (B)(6) TEST METHOD RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. THE INSTRUCTION FOR USE (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. 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 REAGENT LOT INFORMATION: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). REAGENT LOT: 062271. EXPIRATION DATE: 10/26/2017. DATE OF MANUFACTURER: 10/26/2016.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP (B)(6) RESULT WAS OBTAINED BY THE CUSTOMER, AND CONSIDERED DISCORDANT COMPARED TO (B)(6) ALTERNATE (B)(6) TEST METHOD RESULTS. THE PATIENT HAD INITIALLY TESTED POSITIVE FOR (B)(6) FROM AN ALTERNATE LABORATORY, AND TEST METHOD. THE PATIENT REQUESTED (B)(6) VERIFICATION TESTING THAT WAS PERFORMED AT THIS LABORATORY. DUE TO THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULT, REPEAT (B)(6) TESTING WAS PERFORMED BY THE CUSTOMER ON THE ADVIA CENTAUR XP, ADVIA CENTAUR XPT, AND THE RESULTS WERE (B)(6). THE PATIENT SAMPLE WAS REPEATED ON THE INITIAL ALTERNATE (B)(6) TEST METHOD, AND THE RESULT (B)(6). THE PATIENT SAMPLE WAS TESTED ON A SECOND ALTERNATE (B)(6) TEST METHOD, AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON A THIRD ALTERNATE (B)(6) TEST METHOD (PCR), AND THE RESULT WAS (B)(6). A CORRECTED REPORT ((B)(6)) WAS ISSUED BY THE CUSTOMER. THERE ARE NO REPORTS THAT PATIENT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460426 ADVIA CENTAUR XP HCV (AHCV) ASSAY HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 062270 00630414473161

    Patients

    Seq Age Sex Outcome Treatment
    1