BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 5173253 · Received October 24, 2015

    Report

    Report Number
    1219913-2015-00161
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 8, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K012183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1219913-2015-00161 WAS SUBMITTED ON 10/08/2015 REPORTING A POSITIVE ADVIA CENTAUR XP TOXOPLASMA G RESULT THAT DID NOT MATCH PREVIOUS RESULTS OR RESULTS BY ALTERNATE METHODS. MDR 1219913-2015-00161 SUPPLEMENTAL 1 WAS FILED ON NOVEMBER 25, 2015 WITH THE RESULTS OF SIEMENS INITIAL TESTING. MARCH 30, 2016 - ADDITIONAL INFORMATION: SIEMENS WAS UNABLE TO PERFORM ANA AND AMA TESTING ON THE SAMPLE. SIEMENS REVIEWED THE COMPLAINT HANDLING DATABASES AND THERE WERE NO OTHER COMPLAINTS REPORTING FALSE POSITIVE RESULTS WITH THIS LOT OF REAGENTS. THE DISCORDANT POSITIVE RESULT APPEARS TO BE DUE TO AN UNKNOWN INTERFERENT IN THE SAMPLE.

    Additional Manufacturer Narrative · 1

    MDR 1219913-2015-00161 WAS SUBMITTED ON 10/08/2015 REPORTING A POSITIVE ADVIA CENTAUR XP TOXOPLASMA G RESULT THAT DID NOT MATCH PREVIOUS RESULTS OR RESULTS BY ALTERNATE METHODS. NOVEMBER 25, 2015 - ADDITIONAL INFORMATION SIEMENS RECEIVED THE SAMPLE AND TESTED IT INTERNALLY ON TWO REAGENT LOTS OF ADVIA CENTAUR XP TOXOPLASMA G, AND IMMULITE XPI2000 TOXOPLASMA G. THE SAMPLE WAS TREATED WITH A HETEROPHILIC BLOCKING TUBE AND TESTED ON THE ADVIA CENTAUR TOXOPLASMA G ASSAY AND THE IMMULITE 2000 XPI TOXOPLASMA G ASSAY. RESULTS IN IU/ML: ADVIA CENTAUR XP LOT 061208 - PATIENT SAMPLE - NEAT - 55.00 / HBT - 60.10. ADVIA CENTAUR XP LOT 061 211 - PATIENT SAMPLE - NEAT - 58.80 / HBT - 60.23. IMMULITE 2000 XPI LOT 414 - PATIENT SAMPLE - NEAT <5.00 / HBT - <5.00 SIEMENS OBSERVED POSITIVE RESULTS WITH BOTH LOTS OF ADVIA CENTAUR XP TOXOPLASMA G AS WELL AS THE SAMPLE TREATED WITH THE HETEROPHILIC BLOCKING TUBE. A NEGATIVE RESULT WAS OBSERVED WITH THE IMMULITE 2000 TOXOPLASMA G ASSAY. SIEMENS WILL CONTINUE TO PERFORM ADDITIONAL TESTING IF THERE IS ENOUGH SAMPLE LEFT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT (B)(6) ADVIA CENTAUR XP TOXOPLASMA G RESULT IS UNKNOWN. SIEMENS HAS REQUESTED THE SAMPLE FOR TESTING. THE CUSTOMER REPORTED THAT QC WAS IN RANGE INDICATING THAT THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES: "IN GEOGRAPHIC REGIONS THAT HAVE AN APPARENT LOW PREVALENCE OF TOXOPLASMA IGG IN ASYMPTOMATIC POPULATIONS, THE (B)(6) PREDICTIVE VALUE OF ANY ASSAY IS REDUCED DUE TO THE INCREASED POSSIBILITY THAT A (B)(6) RESULT IS ACTUALLY FALSELY (B)(6). AS WITH ALL IN VITRO DIAGNOSTIC ASSAYS, EACH LABORATORY SHOULD DETERMINE ITS OWN REFERENCE RANGE(S) FOR THE DIAGNOSTIC EVALUATION OF PATIENT RESULTS."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A (B)(6) ADVIA CENTAUR XP TOXOPLASMA G RESULT THAT DID NOT MATCH PREVIOUS RESULTS OR RESULTS BY ALTERNATE METHODS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO DISCORDANT ADVIA CENTAUR XP TOXOPLASMA G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705188 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 061208

    Patients

    Seq Age Sex Outcome Treatment
    1