BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G)

    MDR report key: 7291872 · Received February 23, 2018

    Report

    Report Number
    1219913-2018-00095
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 23, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOTICS, INC
    Product Code
    LGD
    UDI-DI
    00630414208459
    PMA / PMN Number
    K102681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WELL WAS DIRTY AND SERUM SPLATTERING WAS FOUND AROUND THE SAMPLE DISPENSE PORT IN THE RING. CUSTOMER CLEANED THE SAMPLE DISPENSE PORT AND VERIFIED SYSTEM PERFORMANCE BY RUNNING PATIENT POOL SAMPLES. CUSTOMER IS NOW REPORTING PATIENTS AND CONTROLS WITHOUT FURTHER CONCERN. THE CALCULATED SPECIFICITY ON THIS ACCOUNT FOR TXOG IS 770/(770+3)= 770/773= 0.996 X 100= 99.6%. THE RELATIVE SPECIFICITY RESULTS FROM THE 3 STUDIES IN THE ADVIA CENTAUR XPT TOXOPLASMA G INSTRUCTIONS FOR USE (IFU OUS VERSION 10629904 REVISION AA, 2016-04) RANGE FROM 99.3% - 99.8%. BASED ON THE AVAILABLE INFORMATION ADVIA CENTAUR XPT TOXOPLASMA G LOT 061227 IS PERFORMING AS INTENDED. A PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER ACTION IS REQUIRED. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE 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." TWO OTHER SAMPLES WERE REPORTED IN THE SAME EVENT. MDR 1219913-2018-00094 WAS FILED FOR (B)(6) AND MDR 1219913-2018-00096 WAS FILED FOR (B)(6).

    Description of Event or Problem · 1

    CUSTOMER OBSERVED A REACTIVE ADVIA CENTAUR XPT TOXOPLASMA IGG (TOXO G) RESULT THAT WAS NEGATIVE UPON REPEAT TESTING IN DUPLICATE AND BY AN ALTERNATE METHOD. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE INITIALLY REACTIVE ADVIA CENTAUR XPT TOXO G RESULT. TWO OTHER SAMPLES WERE REPORTED IN THE SAME EVENT. MDR 1219913-2018-00094 WAS FILED FOR (B)(6) AND MDR 1219913-2018-00096 WAS FILED FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136064 ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOTICS, INC N/A 060406227 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR