BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6085340 · Received November 8, 2016

    Report

    Report Number
    1219913-2016-00213
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 26, 2016
    Report Date
    May 9, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MZF
    PMA / PMN Number
    BP140103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00213 ON NOVEMBER 08, 2016. SIEMENS FILED THE MDR 1219913-2016-00213 SUPPLEMENTAL REPORT 1 ON MARCH 16, 2017. ON 05/03/2017 ADDITIONAL INFORMATION: SIEMENS RECEIVED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. SIEMENS WAS UNABLE TO TEST THE PATIENT SAMPLE WITH LOT 117103 THAT WAS USED BY THE CUSTOMER, AS IT EXPIRED ON 2/18/2017. THE PATIENT SAMPLE WAS RECEIVED AFTER THE REAGENT EXPIRATION DATE. THE PATIENT SAMPLE WAS TESTED ON BOTH (B)(4) REAGENT LOTS 117111 AND 117113 IN REPLICATES OF 1. THE RESULTS WERE (B)(6). THE RESULTS OF THE SAMPLE TESTED BY SIEMENS DID NOT CONFIRM THE CUSTOMER'S OBSERVATION OF AN INITIAL (B)(6) RESULT. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, THERE MAY HAVE BEEN A POSSIBLE ISSUE WHEN THE SAMPLE WAS ORIGINALLY TESTED. PRE-ANALYTICAL VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. WHILE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE (B)(6) RESULT, SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS OR SAMPLE ISSUE. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP (B)(6) RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE (B)(6) ADVIA CENTAUR XP CHIV RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. THE IFU STATES IN THE LIMITATIONS SECTION: "THE CALCULATED VALUES FOR (B)(6) 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 (B)(6) MAY NOT DETECT ALL INFECTED INDIVIDUALS. A (B)(6) TEST RESULT DOES NOT EXCLUDE THE POSSIBILITY OF EXPOSURE TO OR INFECTION WITH (B)(6). (B)(6) ANTIBODIES AND/OR P24 ANTIGEN MAY BE UNDETECTABLE IN SOME STAGES OF THE INFECTION AND IN SOME CLINICAL CONDITIONS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00213 ON NOVEMBER 08, 2016. ON 03/13/2017 ADDITIONAL INFORMATION: THE FIELD SERVICE ENGINEER (FSE) CHECKED THE SYSTEM AND NO ISSUES FOUND. THE SAMPLE AVAILABLE IS AVAILABLE FOR ADDITIONAL TESTING AND WILL BE SENT TO SIEMENS HEALTHCARE DIAGNOSTICS.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) RESULT WAS OBTAINED ON A PATIENT SAMPLE DURING A ROUTINE MEDICAL CHECK. THE CUSTOMER QUESTIONED THE RESULT SINCE THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH (B)(6). THE PATIENT SAMPLES WAS REPEATED AND THE RESULT WAS (B)(6). PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE (B)(6) ADVIA CENTAUR XP CHIV RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737531 ADVIA CENTAUR XP HIV AG/AB COMBO (CHIV) ASSAY CHIV IMMUNOASSAY MZF SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 33674103

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR