BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY

    MDR report key: 3771078 · Received April 24, 2014

    Report

    Report Number
    1219913-2014-00101
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 13, 2014
    Report Date
    April 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LFX
    PMA / PMN Number
    K003412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT RESULT IS UNKNOWN. THE ISSUE APPEARS TO BE PATIENT SPECIFIC SINCE MULTIPLE SAMPLES FROM THE SAME PATIENT EXHIBIT THE ISSUE. SIEMENS HAS REQUESTED THE SAMPLES FOR TESTING. THE INTENDED USE SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "THE USE OF THE ADVIA CENTAUR RUBELLA G ASSAY TO DIAGNOSE RECENT INFECTION BY TESTING ACUTE AND CONVALESCENT SAMPLES IS NOT RECOMMENDED. THE CALCULATED VALUES FOR RUBELLA IGG IN A 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 RUBELLA IGG ASSAY USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. THE REPORTED IGG LEVEL CANNOT BE CORRELATED TO AN ENDPOINT TITER. "

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00101 ON (B)(6) 2014 FOR FALSE POSITIVE ADVIA CENTAUR XP RUBELLA G RESULTS. POSITIVE RESULTS WERE OBSERVED ON TWO SAMPLES FROM THE SAME PATIENT. ON (B) (6) 2014 - ADDITIONAL INFORMATION; SIEMENS RECEIVED A SAMPLE FROM THE CUSTOMER AND TESTED IT WITH TWO REAGENT LOTS OF ADVIA CENTAUR XP RUBELLA G. THE SAMPLE WAS ALSO TESTED WITH HETEROPHILIC ANTIBODY BLOCKING TUBES (HBT). (B)(6). SIEMENS CONFIRMED THE CUSTOMER'S ADVIA CENTAUR XP RUBELLA G RESULTS INDICATING THAT THE ISSUE IS NOT SITE SPECIFIC OR REAGENT LOT SPECIFIC. BASED ON THE HBT RESULTS, THE POSITIVE RESULTS ARE NOT CAUSED BY HAMA OR HETEROPHILIC ANTIBODIES. NO FURTHER SAMPLE IS AVAILABLE FOR ADDITIONAL INVESTIGATION. THE CUSTOMER TESTS APPROXIMATELY 300 SAMPLES A MONTH. THE SYSTEM IS PERFORMING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBSERVED FALSE POSITIVE RESULTS FROM ONE PATIENT USING THE ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY. THE RESULT WAS POSITIVE WITH MULTIPLE SAMPLES. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR THAT THERE WERE ANY ADVERSE HEALTH CONSEQUENCES BASED ON THE FALSE POSITIVE ADVIA CENTAUR XP RUBG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250091 ADVIA CENTAUR XP RUBELLA G (RUB G) ASSAY RUBELLA G IMMUNOASSAY LFX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 068177

    Patients

    Seq Age Sex Outcome Treatment
    1