BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY

    MDR report key: 5169757 · Received October 22, 2015

    Report

    Report Number
    1219913-2015-00160
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Date of Event
    December 9, 2014
    Report Date
    October 6, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS IS UNKNOWN. THE PATIENT SAMPLES ARE NOT AT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION AT THE MANUFACTURER SITE. SERVICE WAS NOT DISPATCHED FOR THIS ISSUE. THE CUSTOMER HAD SWITCHED OFF THE INSTRUMENTS. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE IFU STATES IN THE LIMITATIONS SECTION: "CURRENTLY AVAILABLE ASSAYS FOR THE DETECTION OF P24 ANTIGEN AND/OR ANTIBODIES TO HIV-1 AND/OR HIV-2 MAY NOT DETECT ALL INFECTED INDIVIDUALS. A (B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH HIV. HIV ANTIBODIES AND/OR P24 ANTIGEN MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS." THE CUSTOMER HAS NOT PROVIDED THE LOT NUMBERS, THEREFORE THE UDI NUMBERS CAN NOT BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD SWITCHED OFF THE INSTRUMENTS AND THE DATA COULD NOT BE OBTAINED. THE CUSTOMER IS NOT GOING TO BE PROVIDING ANY DATA OR INFORMATION WITH REGARDS TO THIS EVENT. SIEMENS IS UNABLE TO PROVIDE ANY FURTHER INFORMATION OR POSSIBLE CAUSES FOR THE FALSE NEGATIVE RESULTS. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULTS WERE OBTAINED ON SAMPLES FROM SEVERAL PATIENTS FOR THE PERIOD DECEMBER 2014 THRU MAY 2015 AND WERE DISCORDANT WITH AN ALTERNATE METHOD. THE RESULTS FROM THE ALTERNATE METHOD WERE (B)(6). WESTERN BLOT TESTING WAS ALSO PERFORMED ON THE PATIENT SAMPLES AT A LATER DATE. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700270 ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1