BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 3716376 · Received April 1, 2014

    Report

    Report Number
    1219913-2014-00079
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    January 8, 2014
    Report Date
    March 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K012183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00079 ON APRIL 01, 2014. ON 05/23/2014 ADDITIONAL INFORMATION: THE CUSTOMER SENT ONE PATIENT SAMPLE TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. MULTI LOT TESTING WAS PERFORMED USING THREE TOXOPLASMA G LOTS. THE SAMPLE TESTED REACTIVE FOR TOXOPLASMA G ACROSS LOT NUMBERS 061196, 061197, AND 061198. TOXOPLASMA G RESULTS (IU/ML): (B)(4). THE PATIENT SAMPLE WAS TESTED FOR TOXOPLASMA M (TOX M) AND THE RESULT WAS NON-REACTIVE. RESULTS (INDEX) WITH LOT # 080239: 0.31. THE PATIENT SAMPLE WAS TESTED FOR ANA ELISA AND AMA ELISA PRESENCE. THE ANA ELISA (ANA-ELISA MEASURES THE PRESENCE OF ANTI-NUCLEAR ANTIBODIES ASSOCIATED WITH SYSTEMIC LUPUS ERYTHEMATOSUS OR A NUMBER OF OTHER AUTOIMMUNE DISEASES) YIELDED A QUALITATIVE NEGATIVE (18.9 IU/ML) RESULT FOR THE PRESENCE OF ANTI-NUCLEAR ANTIBODIES IN THE SAMPLE. (CUT-OFF: NEGATIVE <23 IU/ML AND POSITIVE >=23 IU/ML). THE AMA ELISA (ANTI-MITOCHONDRIAL M2 ELISA MEASURES THE PRESENCE OF AUTOANTIBODIES FORMED AGAINST MITOCHONDRIA, SPECIFICALLY M2 ANTIGENS (INNER MITOCHONDRIAL MEMBRANE ANTIGENS) ASSOCIATED WITH LIVER DISEASE OR OTHER AUTOIMMUNE DISEASES) YIELDED A QUALITATIVE NEGATIVE FOR THE PRESENCE OF ANTI-MITOCHONDRIAL ANTIBODIES AND A QUANTITATIVE NEGATIVE OF 0.4 MRC U/ML. (CUT- OFF: NEGATIVE <2.5 MRC U/ML, EQUIVOCAL 2.5-4.0 MRC U/ML, AND POSITIVE > 4.0 MRC U/ML.) THE PATIENT SAMPLE WAS RUN USING HBT (HETEROPHILIC BLOCKING TUBE) AND NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE). THE RESULTS WERE REACTIVE. TOXOPLASMA G RESULTS (IU/ML): HBT TUBE: 16.7, NABT TUBE: 13.11. BASED ON THE ABOVE TESTING AND RESULTS, THIS IS A SAMPLE SPECIFIC ISSUE. THE SAMPLE IS NOT POSITIVE FOR TOXO M. THE SAMPLE DOES NOT CONTAIN ANTI-NUCLEAR ANTIBODIES (ANA) OR ANTI-MITOCHONDRIAL ANTIBODIES (AMA). THE SAMPLE DID NOT DECREASE IN SIGNAL WHEN USING SCANTIBODIES HBT TUBES TO TEST FOR HETEROPHILIC INTERACTION OR SCANTIBODIES NABT TUBES TO TEST FOR NON-SPECIFIC INTERACTIONS. THE SAMPLE MAY CONTAIN AN UNKNOWN INTERFERING SUBSTANCE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. HBT (HETEROPHILIC BLOCKING TUBE) AND NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE) TUBES WERE SENT TO THE CUSTOMER FOR FURTHER TESTING. THE RESULTS WERE POSITIVE.TOXOPLASMA G RESULTS (IU/ML):HBT TUBE: 12.6NABT TUBE: 11.5SIEMENS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. THE IFU STATES IN THE LIMITATIONS SECTION:"IN GEOGRAPHIC REGIONS THAT HAVE AN APPARENT LOW PREVALENCE OF TOXOPLASMA IGG IN ASYMPTOMATIC POPULATIONS, THE POSITIVE PREDICTIVE VALUE OF ANY ASSAY IS REDUCED DUE TO THE INCREASED POSSIBILITY THAT A POSITIVE RESULT IS ACTUALLY FALSELY POSITIVE. AS WITH ALL IN VITRO DIAGNOSTIC ASSAYS, EACH LABORATORY SHOULD DETERMINE ITS OWN REFERENCE RANGE(S) FOR THE DIAGNOSTIC EVALUATION OF PATIENT RESULTS. HUMAN ANTI-MOUSE ANTIBODIES (HAMA) OR HETEROPHILE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM INDIVIDUALS EXPOSED TO MOUSE OR ANIMAL IMMUNOGLOBULINS FROM NATURAL SOURCES OR AS PART OF DISEASE THERAPIES. THESE ANTIBODIES MAY INTERFERE WITH THE ADVIA CENTAUR TOXO G ASSAY AND GIVE FALSELY POSITIVE OR FALSELY NEGATIVE RESULTS. THESE SAMPLES SHOULD NOT BE TESTED. THE PRESENCE OF ANTI-NUCLEAR ANTIBODIES (ANA) AND ANTI-MITOCHONDRIAL ANTIBODIES (AMA) IN SAMPLES FROM PATIENTS WITH AUTOIMMUNE SYNDROME MAY INTERFERE WITH THE ADVIA CENTAUR TOXO G ASSAY AND GIVE FALSELY POSITIVE OR FALSELY NEGATIVE RESULTS. THESE SAMPLES SHOULD NOT BE TESTED."

    Description of Event or Problem · 1

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) FALSE POSITIVE RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE HISTORICAL RESULTS FOR THIS PATIENT WERE NEGATIVE. THE SAMPLES WERE TESTED WITH ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. TOXOPLASMA M (TOXO M) RESULTS WERE ALL NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXOPLASMA G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196362 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 061195

    Patients

    Seq Age Sex Outcome Treatment
    1