BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HCV (AHCV)

    MDR report key: 6150848 · Received December 7, 2016

    Report

    Report Number
    1219913-2016-00233
    Event Type
    Malfunction
    Date Received
    December 7, 2016
    Date of Event
    November 3, 2016
    Report Date
    January 6, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZO
    PMA / PMN Number
    P030056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE (B)(6) ADVIA CENTAUR XP HCV RESULT IS UNKNOWN. QC WAS IN RANGE AT THE TIME OF THE TESTING. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES : "THE RESULTS FROM THIS OR ANY OTHER DIAGNOSTIC KIT SHOULD BE USED AND INTERPRETED ONLY IN THE CONTEXT OF THE OVERALL CLINICAL PICTURE. A NEGATIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO HEPATITIS C VIRUS. THE CALCULATED VALUES FOR HEPATITIS C IN A GIVEN SPECIMEN AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. THE REPORTED ANTIBODY LEVEL CANNOT BE CORRELATED TO AN ENDPOINT TITER."

    Additional Manufacturer Narrative · 1

    SIEMENS SUBMITTED MDR 1219913-2016-00233 ON DECEMBER 7, 2016 REGARDING NEGATIVE RESULTS ON A PATIENT SAMPLE USING THE ADVIA CENTAUR XP AHCV ASSAY. THE RESULTS WERE REACTIVE ON PCR. DECEMBER 27, 2016 - ADDITIONAL INFORMATION: TESTING WAS PERFORMED ON TWO LOTS OF ADVIA CENTAUR AHCV REAGENT (062264, 062265). THE SAMPLE TESTED WAS NOT REACTIVE TO EITHER OF THE REAGENT LOTS. REAGENT LOT 062264 (B)(6). REAGENT LOT 062265 (B)(6). SIEMENS ALSO PERFORMED EXPERIMENTAL TESTING WITH THE SEPARATE SOLID PHASE COMPONENTS OF THE ASSAY (C200, C22, NS5, UNCONJUGATED MAGNETIC BEAD). THE SAMPLE TESTED, HOWEVER, SHOWS REACTIVITY TO THE C22 ANTIGEN COATED MAGNETIC BEAD, INDICATING THAT THIS A SPECIFIC RESPONSE. THE SAMPLE DID NOT REACT TO THE OTHER ANTIGENS. THIS INDICATES THAT THE SAMPLE CONTAINS ANTIBODIES THAT SPECIFICALLY BIND TO THE C22 ANTIGEN. IT APPEARS AS THOUGH THE SAMPLE DOES NOT CONTAIN ENOUGH ANTIBODIES TO ELICIT AN ANTIBODY RESPONSE FROM THE ADVIA CENTAUR AHCV ASSAY.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED (B)(6) RESULTS ON A PATIENT SAMPLE USING THE ADVIA CENTAUR XP HCV (AHCV) ASSAY. THE RESULTS WERE (B)(6) ON PCR. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP HCV RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804071 ADVIA CENTAUR XP HCV (AHCV) HEPATITIS C VIRUS (ANTI-HCV) ASSAY MZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 6514267

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR