BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 6612026 · Received June 5, 2017

    Report

    Report Number
    1219913-2017-00136
    Event Type
    Malfunction
    Date Received
    June 5, 2017
    Date of Event
    February 24, 2017
    Report Date
    July 11, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K102681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00136 ON 06/05/2017 FOR FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULTS. 06/19/17 - ADDITIONAL INFORMATION: THE CUSTOMER TESTED THE PATIENT SAMPLE WITH NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT), AND HETEROPHILIC BLOCKING TUBE (HBT), AND THE TOXO G RESULTS WERE SIMILAR (POSITIVE). THE SAMPLE WAS A PRIMARY TUBE WITH GEL. THERE IS NO INFORMATION PROVIDED ON PATIENT TREATMENT. (B)(6). THE SAMPLE WAS TREATED WITH HBT/NABT AND THE VALUE DID NOT CHANGE, THEREFORE HETEROPHILIC ANTIBODIES DO NOT APPEAR TO BE CAUSING THE ELEVATED RESULT. THERE IS NO PATIENT SAMPLE AVAILABLE FOR EVALUATION BY SIEMENS. THE CUSTOMER HAS NOT PROVIDED THE TOTAL NUMBER OF SAMPLES TESTED WITH THE CENTAUR TOXOPLASMA IGG REAGENT LOT 061221, THEREFORE ASSAY SPECIFICITY IS UNKNOWN. THE CAUSE FOR THE ELEVATED ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. 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." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT POSITIVE ADVIA CENTAUR XP TOXOPLASMA G RESULT 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

    FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULTS WERE OBTAINED BY THE CUSTOMER, AND CONSIDERED DISCORDANT COMPARED TO NEGATIVE TOXO G RESULTS ON TWO OTHER ALTERNATE TEST METHODS. THE PATIENT WAS POSITIVE FOR TOXO G IN (B)(6), AND REPEAT POSITIVE APPROXIMATELY 3 MONTHS LATER. THE POSITIVE TOXO G RESULTS WERE REPORTED, AND A CORRECTIVE REPORT ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TOXO G RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392512 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 061221

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR