BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HAV TOTAL (AHAVT)

    MDR report key: 5464010 · Received February 26, 2016

    Report

    Report Number
    1219913-2016-00047
    Event Type
    Malfunction
    Date Received
    February 26, 2016
    Date of Event
    September 8, 2015
    Report Date
    February 10, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOL
    PMA / PMN Number
    P040017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULT IS UNKNOWN. SIEMENS HAS REQUESTED THE SAMPLE FOR INVESTIGATION. US INSTRUCTIONS FOR USE INTENDED USE SECTION STATES: "THE (B)(6) ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING (B)(6) OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION." OUS INSTRUCTIONS FOR USE INTENDED USE SECTION STATES: "AS ASSAY FOR (B)(6) IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING , OR FOR THE DETECTION OF (B)(6) AFTER VACCINATION."

    Additional Manufacturer Narrative · 1

    MDR 1219913-2016-00047 WAS FILED ON FEBRUARY 10, 2016 REPORTING A RESULT THAT WAS REPEATEDLY (B)(6) WITH THE ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY. THE PATIENT WAS (B)(6) BY AN ALTERNATE METHOD AND PCR. APRIL 4, 2016 - ADDITIONAL INFORMATION: THE CUSTOMER PROVIDED THE AHAVT LOT NUMBER AS 073177 EXPIRATION DATE SEPTEMBER 28, 2016. SIEMENS RECEIVED THE SAMPLE AND PERFORMED THE FOLLOWING TESTING. THE SAMPLE WAS TESTED WITH ADVIA CENTAUR HAV TOTAL REAGENT LOT 104072 BOTH NEAT AND AFTER TREATMENT WITH AN HBT TUBE. NEAT SAMPLE (B)(6). TREATED SAMPLE (B)(6). THE SAMPLE WAS TESTED WITH ADVIA CENTAUR HAV IGM REAGENT LOTS 070164 AND 070165 BOTH NEAT AND AFTER TREATMENT WITH AN NABT TUBE. REAGENT LOT 070164 NEAT SAMPLE >ASSAY RANGE (B)(6). TREATED SAMPLE >ASSAY RANGE (B)(6). REAGENT LOT 070165 NEAT SAMPLE >ASSAY RANGE (B)(6). TREATED SAMPLE >ASSAY RANGE (B)(6). THESE RESULTS INDICATE THE ISSUE IS SPECIFIC TO THIS SAMPLE OR PATIENT. THE LIMITATIONS SECTION OF THE US INSTRUCTIONS FOR USE FOR HAV TOTAL 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 NONREACTIVE TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO HEPATITIS A VIRUS."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A RESULT THAT IS REPEATEDLY (B)(6) WITH ADVIA CENTAUR XP HAV TOTAL (AHAVT) ASSAY. THE PATIENT IS (B)(6) BY AND ALTERNATE METHOD AND PCR. THE PATIENT HAD SEVERAL BLOOD DRAWS THAT ARE (B)(6) ON THE ADVIA CENTAUR XP AHAVT ASSAY AND (B)(6) BY OTHER METHODS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120508 ADVIA CENTAUR XP HAV TOTAL (AHAVT) HAVT IMMUNOASSAY LOL SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1