BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 4096514 · Received September 17, 2014

    Report

    Report Number
    1219913-2014-00229
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 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 1219913-2014-00229 ON (B)(6) 2014. (B)(6) 2014 ADDITIONAL INFORMATION: THE CUSTOMER SENT TWO SAMPLES FROM THE SAME PATIENT TO SIEMENS HEALTHCARE DIAGNOSTICS FOR FURTHER TESTING AND INVESTIGATION. THE SAMPLES RECEIVED WERE (B)(4). BOTH SAMPLES TESTED POSITIVE FOR TOXOPLASMA G ACROSS LOT NUMBERS 061197, 061199, AND 061201. TOXOPLASMA G RESULTS (IU/ML): (B)(6). SIEMENS IS STILL INVESTIGATING.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00229 ON SEPTEMBER 17, 2014. SIEMENS FILED THE MDR 1219913-2014-00229 SUPPLEMENTAL REPORT 1 ON OCTOBER 23, 2014. ON 10/31/2014 ADDITIONAL INFORMATION: THE PATIENT SAMPLES WERE TESTED FOR ANA AND AMA PRESENCE. THE ANA AND AMA RESULTS ARE NEGATIVE FOR BOTH SAMPLES 14-13608A AND 14-13608B. BASED ON THE ABOVE TESTING AND RESULTS, THIS IS A SAMPLE SPECIFIC ISSUE. THESE SAMPLES DO NOT CONTAIN ANTI-NUCLEAR ANTIBODIES (ANA) OR ANTI-MITOCHONDRIAL ANTIBODIES (AMA). THESE SAMPLES MAY CONTAIN AN UNKNOWN INTERFERING SUBSTANCE. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "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."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. THE RESULTS FROM THE REFERENCE TESTING INDICATE THAT THE DISCORDANT RESULTS ARE SAMPLE SPECIFIC. SIEMENS HAS REQUESTED THE PATIENT SAMPLES 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) POSITIVE RESULTS WERE OBTAINED FOR THREE SAMPLES FROM THE SAME PATIENT OVER A PERIOD OF THREE MONTHS. THE SAMPLE FROM (B)(6) 2014 WAS TESTED ON AN ALTERNATE METHOD AND THE RESULT WAS NEGATIVE. THE SAMPLE FROM (B)(6) 2014 WAS SENT TO AN EXPERT LABORATORY AND TESTED ON TWO ALTERNATE METHODS. THE RESULTS WERE NEGATIVE. THE CUSTOMER RECEIVED A NEW SAMPLE ((B)(4) 2014) AND THE RESULT WAS POSITIVE ON THE ADVIA CENTAUR XP. THE SAMPLE FROM (B)(4) 2014 WAS TESTED AT ANOTHER LABORATORY ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. IT IS UNKNOWN WHICH IS THE CORRECT RESULT (POSITIVE OR 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
    574741 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 198, 199, AND 201

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR