BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 6341550 · Received February 17, 2017

    Report

    Report Number
    1219913-2017-00025
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 3, 2017
    Report Date
    April 4, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K102681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MDR 1219913-2017-00025 WAS FILED ON FEBRUARY 17, 2017 REPORTING A REPRODUCIBLE POSITIVE RESULT ON THE ADVIA CENTAUR XP, TOXOPLASMA G (TOXO G) ASSAY, THAT IS NEGATIVE BY ALTERNATE METHODS. THE POSITIVE RESULTS DO NOT MATCH THE CLINICAL EXPECTATIONS FOR THE PATIENT. MARCH 2, 2017 - ADDITIONAL INFORMATION: SIEMENS RECEIVED THE SAMPLE AND THE RETURNED SAMPLE WAS TESTED NEAT AND AFTER TREATMENT WITH A HETEROPHILIC BLOCKING TUBE. THE SAMPLES WERE TESTED ON THE IMMULITE 2000 TXP KIT 427 AS WELL AS ADVIA CENTAUR TOXOPLASMA G LOT 061218 AND 061219. (B)(6). SIEMENS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    MDR 1219913-2017-00025 WAS FILED ON FEBRUARY 17, 2017 REPORTING A REPRODUCIBLE POSITIVE RESULT ON THE ADVIA CENTAUR XP, TOXOPLASMA G (TOXO G) ASSAY, THAT IS NEGATIVE BY ALTERNATE METHODS. THE POSITIVE RESULTS DO NOT MATCH THE CLINICAL EXPECTATIONS FOR THE PATIENT. MDR 1219913-2017-00025 SUPPLEMENTAL 1 WAS FILED ON MARCH 9, 2017 WITH INVESTIGATION RESULTS. MARCH 22, 2017 - ADDITIONAL INFORMATION: CUSTOMER HAS A SAMPLE THAT CONSISTENTLY READS REACTIVE (~35 - 45 IU/ML) WITH ADVIA CENTAUR TOXOPLASMA IGG KIT LOT 218 BUT NONREACTIVE WITH ALTERNATE METHOD TOXOPLASMA IGG ASSAYS. THE SAMPLE IS NONREACTIVE WITH THE ADVIA CENTAUR TOXOPLASMA IGM ASSAY. THE SAMPLE WAS SENT TO SIEMENS FOR EVALUATION. WHEN SIEMENS TESTED THE SAMPLE WITH ADVIA CENTAUR TOXOPLASMA IGG KIT LOT 218 THE CUSTOMER'S REACTIVE RESULTS (37.1 IU/ML) WERE DUPLICATED. SIEMENS ALSO TESTED THE SAMPLE WITH ADVIA CENTAUR TOXOPLASMA IGG KIT LOT 219 AND IT ALSO RECOVERED REACTIVE (37.0 IU/ML) SO THIS IS NOT A LOT SPECIFIC ISSUE. SIEMENS TREATED THE SAMPLE WITH A HETEROPHILIC BLOCKING TUBE (HBT) AND WHEN IT WAS TESTED WITH KIT LOTS 218 AND 219 IT REMAINED REACTIVE (~ 50 IU/ML) SO HETEROPHILIC ANTIBODIES ARE NOT ELEVATING THE ADVIA CENTAUR TOXOPLASMA IGG RESULT. WHEN SIEMENS TESTED THE SAMPLE WITH THE IMMULITE TOXOPLASMA IGG ASSAY IT RECOVERED NONREACTIVE (<5.00 IU/ML). THE CUSTOMER HAS NOT BEEN ABLE TO PROVIDE THE TOTAL NUMBER OF NEGATIVE SAMPLES THEY TESTED WITH ADVIA CENTAUR TOXOPLASMA IGG KIT LOT 218 SO SPECIFICITY CANNOT BE CALCULATED. ROOT CAUSE CANNOT BE DETERMINED. THERE COULD BE SOME UNKNOWN INTERFERENT ELEVATING THE ADVIA CENTAUR TOXOPLASMA IGG RESULT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT POSITIVE ADVIA CENTAUR XP TOXOPLASMA G RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "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."

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A REPRODUCIBLE POSITIVE RESULT ON THE ADVIA CENTAUR XP, TOXOPLASMA G (TOXO G) ASSAY, THAT IS NEGATIVE BY ALTERNATE METHODS. THE POSITIVE RESULTS DO NOT MATCH THE CLINICAL EXPECTATIONS FOR THE PATIENT. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE POSITIVE ADVIA CENTAUR XP TOXO G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123423 ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY, LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 72355218

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR