BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 6590701 · Received May 25, 2017

    Report

    Report Number
    1219913-2017-00132
    Event Type
    Malfunction
    Date Received
    May 25, 2017
    Date of Event
    May 10, 2017
    Report Date
    June 19, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE REAGENT LOT NUMBER USED FOR THE PATIENT TESTING HAS BEEN REQUESTED. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00132 ON MAY 25, 2017. ON 06/07/2017 ADDITIONAL INFORMATION: PATIENT IS FEMALE, (B)(6). PATIENT IS PREGNANT, (B)(6). TREATMENT: CLEXANE. TOXOPLASMA G RESULTS (INDEX): ADVIA CENTAUR XP: 117.6 POSITIVE, ALTERNATE METHOD: NEGATIVE. THE QUALITY CONTROL WAS IN RANGE. THE REAGENT LOT NUMBER USED AT THE TIME OF TESTING WAS TOXO G LOT 220. EXPIRATION DATE: 11/10/2017. THE UDI # IS (B)(4). SAMPLE TYPE VACUTAINER TUBE WITH GEL BARRIER. THE PATIENT SAMPLE WAS NOT AVAILABLE FOR EVALUATION AT THE MANUFACTURER SITE. THE CUSTOMER TESTED 4015 NEGATIVE SAMPLES WITH LOT 061220, SO THEIR SPECIFICITY WOULD BE 99.95% (4015/4017). THE RELATIVE SPECIFICITY RESULTS FROM THE 3 STUDIES IN THE ADVIA CENTAUR XP TOXOPLASMA G INSTRUCTIONS FOR USE (IFU) (10629904 REVISION AA) RANGE FROM 99.3% - 99.8%. THE CAUSE OF THE ELEVATED RESULTS CANNOT BE DETERMINED. BASED ON THE AVAILABLE INFORMATION, THE ADVIA CENTAUR XP TOXOPLASMA IGG LOT 061220 IS MEETING THE SPECIFICITY CLAIMS IN THE IFU. THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULTS WERE OBTAINED ON TWO SAMPLES FROM THE SAME PATIENT. THE PATIENT IS PREGNANT AND IS ON TREATMENT WITH HEPARIN. THE RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE QUESTIONED. BOTH PATIENT SAMPLES WERE RUN ON TWO ALTERNATE METHODS AND THE RESULTS WERE 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
    371088 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1