BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9118770 · Received September 25, 2019

    Report

    Report Number
    1219913-2019-00174
    Event Type
    Malfunction
    Date Received
    September 25, 2019
    Date of Event
    September 4, 2019
    Report Date
    December 6, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON (B)(6) 2019. (B)(6) 2019 ADDITIONAL INFORMATION: SIEMENS ATTEMPTED TO ACQUIRE THE NECESSARY INFORMATION TO INVESTIGATE THIS ISSUE ON (B)(6) 2019 AND AGAIN ON (B)(6) 2019 NO FEEDBACK OR RESPONSE WAS PROVIDED BY THE REGION. FALSE NON-REACTIVE (NEGATIVE) RESULTS OBTAINED WITH ADVIA CENTAUR CP CHIV LOT 117191. THE SAME SAMPLE RESULTED REACTIVE WITH ELISA AND WESTERN BLOT. THE CUSTOMER SERVICE ENGINEER (CSE) HAS GONE ONSITE AND FOUND ELECTRICITY GROUNDING WAS OUT OF INSTRUMENT SPECIFICATIONS. THE TEAM RESOLVED THIS ISSUE AND REPLACED MAJOR PARTS ON THE SYSTEM. THE TEAM FEELS THE ISSUE WAS RANDOM WITH VERY LOW FREQUENCY AND MOST PROBABLY DUE TO SPIKING OF THE GROUNDING VOLTAGE. THE ADVIA CENTAUR CP CHIV IFU (10629936_EN REV. J, 2019-08) STATES THE INTENDED USE OF THE ASSAY IS TO AID IN THE DIAGNOSIS OF HIV INFECTION: "THE ADVIA CENTAUR HIV AG/AB COMBO (CHIV) ASSAY IS AN IN VITRO DIAGNOSTIC IMMUNOASSAY FOR THE SIMULTANEOUS QUALITATIVE DETECTION OF HUMAN IMMUNODEFICIENCY VIRUS P24 ANTIGEN AND ANTIBODIES TO HUMAN IMMUNODEFICIENCY VIRUSES TYPE 1 (INCLUDING GROUP "O") AND TYPE 2, IN SERUM AND PLASMA (POTASSIUM-EDTA) TO AID IN THE DIAGNOSIS OF HIV INFECTION, USING THE ADVIA CENTAUR CP SYSTEM." 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 NEGATIVE 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." BASED ON THE SERVICE ACTIVITY RELATED TO THIS COMPLAINT, IT IS INCONCLUSIVE TO DETERMINE WHAT MECHANICAL MALFUNCTION COULD HAVE CONTRIBUTED TO THE FALSE NON-REACTIVE RESULT. THE SYSTEM IS OPERATIONAL. NO PRODUCT PROBLEM IDENTIFIED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2019-00173 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CP CHIV RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE IFU STATES IN THE LIMITATIONS SECTION: "THE CALCULATED VALUES FOR ANTI-HIV AND/OR P24 ANTIGEN 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 AND/OR P24 ANTIGEN CANNOT BE CORRELATED TO AN ENDPOINT TITER. 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." MDR 1219913-2019-00173 (JUNE 29TH INITIAL TESTING) WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A FALSE (B)(6) ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED WITH THE ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) ASSAY AT A LATER DATE AND THE RESULT WAS (B)(6). THE PATIENT SAMPLE WAS TESTED ON THREE ALTERNATE METHODS AND THE RESULTS WERE (B)(6). A CORRECTED REPORT WAS ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP CHIV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911764 ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 36109191

    Patients

    Seq Age Sex Outcome Treatment
    1