BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REF H10

    MDR report key: 5792259 · Received July 13, 2016

    Report

    Report Number
    1219913-2016-00119
    Event Type
    Malfunction
    Date Received
    July 13, 2016
    Date of Event
    June 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P110041
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE (B)(6) ADVIA CENTAUR XP (B)(6) RESULTS IS UNKNOWN. SIEMENS HAS REQUESTED THE SAMPLE FOR ADDITIONAL TESTING. THE ADVIA CENTAUR HBSAGII INSTRUCTIONS FOR USE (IFU) STATES IN THE LIMITATIONS SECTION "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR HBSAGII TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS." THE ADVIA CENTAUR HAVT US INSTRUCTIONS FOR USE INTENDED USE SECTION STATES: "THE ANTI-HAV ASSAY IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION OR IN THE IDENTIFICATION OF HAV-SUSCEPTIBLE INDIVIDUALS FOR VACCINATION." THE ADVIA CENTAUR HAVT OUS INSTRUCTIONS FOR USE INTENDED USE SECTION STATES: "AS ASSAY FOR ANTI-HAV IS INDICATED AS AN AID IN THE DIAGNOSIS OF PREVIOUS OR ONGOING HEPATITIS A VIRAL INFECTION, OR FOR THE DETECTION OF ANTI-HAV AFTER VACCINATION. CONCOMITANT PRODUCTS: BRAND NAME: ADVIA CENTAUR XP HBSAGII; COMMON DEVICE NAME: HBS IMMUNOASSAY; PRODUCT CODE: LOM; CATALOG#: 10492138; LOT#: 109078; EXPIRATION DATE 01/14/2017; (B)(4). BRAND NAME: ADVIA CENTAUR XP HAV TOTAL (AHAVT); COMMON DEVICE NAME: HAVT IMMUNOASSAY; PRODUCT CODE: LOL; CATALOG#: 05498862; LOT#: 073179; EXPIRATION DATE: 12/18/2016; (B)(4). BRAND NAME: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2); COMMON DEVICE NAME: AHBS2 IMMUNOASSAY; PRODUCT CODE: LOM; CATALOG#: 04670661; LOT#: 119064; EXPIRATION DATE: 01/04/2018; (B)(4).

    Additional Manufacturer Narrative · 1

    SIEMENS FILED MDR 1219913-2016-00119 ON (B)(6) 2016 REPORTING REACTIVE RESULTS FOR ADVIA CENTAUR XP HBSAGII, HAV TOTAL (AHAVT) AND ANTI-HBS2 (AHBS2) THAT DID NOT MATCH THE CLINICAL HISTORY OF THE PATIENT AND AN ALTERNATE METHOD. SIEMENS REQUESTED THE SAMPLE FOR INTERNAL TESTING. ON (B)(6) 2016 SIEMENS TESTED THE SAMPLE BOTH NEAT AND WITH HETEROPHILIC BLOCKING TUBES (HBT) WITH THE SAME REAGENT LOTS WHICH THE CUSTOMER USED. (B)(6). THESE RESULTS INDICATE THE PRESENCE OF ENDOGENOUS INTERFERENTS PRESENT FOR EHIV AND HBSAGII. ADDITIONAL STUDIES ARE BEING PLANNED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED MDR 1219913-2016-00119 ON JUNE 13, 2016 REPORTING REACTIVE RESULTS FOR ADVIA CENTAUR XP (B)(6) THAT DID NOT MATCH THE CLINICAL HISTORY OF THE PATIENT AND AN ALTERNATE METHOD. SIEMENS REQUESTED THE SAMPLE FOR INTERNAL TESTING. SIEMENS FILED MDR 1219913-2016-00119 SUPPLEMENTAL 1 ON OCTOBER 31, 2016 WITH THE RESULTS OF INITIAL TESTING. NOVEMBER 30, 2016. SIEMENS PERFORMED TESTING WHICH INDICATED HETEROPHILIC AND NON-SPECIFIC INTERACTIONS AS A POSSIBLE CAUSE FOR THE DISCORDANT RESULTS. SIEMENS TESTED THE SAMPLE FOR NON-SPECIFIC REACTIVITY TO THE (B)64)ASSAYS. THE SAMPLE WAS TESTED WITH INDIVIDUAL COMPONENTS OF EACH OF THESE ASSAYS (THE BEADS, REAGENT WITHOUT ANTIGEN, AND BUFFERS.) THE SAMPLE REACTED NON-SPECIFICALLY TO THE SOLID PHASE COMPONENTS OF THE (B)(6) ASSAYS. THERE WAS NO BINDING OBSERVED WITH THE (B)(6) ASSAY, WHICH COULD BE INDICATIVE OF TRUE ANTIBODY BRIDGING. (B)(6). RESPONSE CLOSE TO BASELINE. THE SAMPLE WAS ALSO TESTED IN THE (B)(6) CONFIRMATORY ASSAY AND AN INVALID RESULT WAS OBTAINED WHICH IS EXPECTED FOR A SAMPLE THAT IS TRULY (B)(6). INFORMATION WAS PROVIDED THAT THE SAMPLE ALSO RESULTED HIGH FOR RHEUMATOID FACTOR. THE TREATMENT FOR RHEUMATOID ARTHRITIS CONSISTS OF IMMUNOSUPPRESENTS. THE PERFORMANCE OF THE ADVIA CENTAUR (B)(6). THESE ASSAYS HAVE NOT BEEN VALIDATED FOR POPULATIONS OF IMMUNOSUPPRESSED PATIENTS. THE PATIENT'S LAB RESULTS SHOULD BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. ADDITIONAL TESTING AND INFORMATION MIGHT BE REQUIRED FOR DIAGNOSIS.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED (B)(6) RESULTS FOR ADVIA CENTAUR XP (B)(6) THAT DID NOT MATCH THE CLINICAL HISTORY OF THE PATIENT AND AN ALTERNATE METHOD. THERE ARE NO REPORTS OF THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE REACTIVE ADVIA CENTAUR XP (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444348 REF H10 REF H10 LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A REF H10

    Patients

    Seq Age Sex Outcome Treatment
    1