BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7986480 · Received October 19, 2018

    Report

    Report Number
    1219913-2018-00256
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 17, 2018
    Report Date
    November 29, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    UDI-DI
    00630414589749
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2018-00256 ON OCTOBER 19, 2018. ON 11/12/2018 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS NOT AVAILABLE FOR FURTHER TESTING AND INVESTIGATION. THEREFORE, SIEMENS IS UNABLE TO DETERMINE THE ROOT CAUSE. THE WORKER (PATIENT) WAS TREATED WITH ANTIVIRAL THERAPY BASED ON PRESUMPTIVE REACTIVE CHIV RESULTS THAT DID NOT CONFIRM. IT IS NOT KNOWN IF PEP TREATMENT WAS PROVIDED BEFORE THE SAMPLE FROM THE WORKER (PATIENT) WAS DRAWN. THE HIV STATUS OF THE PATIENT IS UNKNOWN. BASED ON THE INFORMATION PROVIDED, SIEMENS IS UNABLE TO RULE OUT A SAMPLE SPECIFIC ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2018-00255 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CHIV RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE IFU STATES IN THE INTERPRETATION OF RESULTS SECTION: "SPECIMENS WITH AN INDEX VALUE GREATER THAN OR EQUAL TO 1.0 ARE CONSIDERED INITIALLY REACTIVE FOR P24 ANTIGEN AND/OR ANTIBODIES TO HIV-1 AND/OR HIV-2 AND SHOULD BE RETESTED IN DUPLICATE AFTER CENTRIFUGATION AT 10,000 X G FOR 10 MINUTES. IF ONE OR BOTH OF THE DUPLICATES ARE REACTIVE, THE SPECIMEN IS REPEATEDLY REACTIVE BY THE ADVIA CENTAUR CHIV ASSAY. NOTE INADEQUATE CENTRIFUGATION MAY RESULT IN A HIGHER RATE OF REPEAT REACTIVE RESULTS THAT MUST BE INVESTIGATED USING SUPPLEMENTAL TESTS FOR HIV-1 AND/OR HIV-2 AND/OR P24 ANTIGEN. REPEATEDLY REACTIVE SPECIMENS MUST BE INVESTIGATED USING SUPPLEMENTAL TESTS FOR HIV-1 AND/OR HIV-2 AND/OR P24 ANTIGEN. IN SPECIMENS GIVING INDETERMINATE SUPPLEMENTAL TEST RESULTS, TESTING OF A SUBSEQUENT SAMPLE DRAWN AT A LATER DATE (SUCH AS 1-6 MONTHS) IS RECOMMENDED. FOR INDIVIDUALS WHO ARE CONFIRMED POSITIVE FOR ANTIBODIES AND/OR P24 ANTIGEN, APPROPRIATE COUNSELING AND MEDICAL EVALUATION SHOULD BE OFFERED AND IS CONSIDERED AN IMPORTANT PART OF TESTING FOR ANTIBODY TO HIV-1 AND HIV-2 AND/OR P24 ANTIGEN." MDR 1219913-2018-00255 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE (B)(6). THE SAMPLE WAS A "NEDDLSTICK" WITH A STAT CHIV TESTING REQUESTED. THE PATIENT SAMPLE WAS TESTED WITH A CONFIRMATORY ELISA METHOD AT ANOTHER LABORATORY AND THE RESULT WAS (B)(6). THE IN-HOUSE NEEDLESTICK RESULT WAS REPORTED AS (B)(6). THE PATIENT RECEIVED PROPHYLACTIC PEP TREATMENT DUE TO THE NEEDLESTICK. IT IS UNKNOWN IF THE TREATMENT WAS ADMINISTERED BEFORE THE SAMPLE WAS DRAWN. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CHIV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826983 ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 44664164 00630414589749

    Patients

    Seq Age Sex Outcome Treatment
    1