BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 8305072 · Received February 5, 2019

    Report

    Report Number
    1219913-2019-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 17, 2019
    Report Date
    April 2, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    UDI-DI
    00630414208459
    PMA / PMN Number
    K102681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR ON FEBRUARY 05, 2019. 03/22/2019 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS RETURNED TO SIEMENS AND ADDITIONAL TESTING WAS PERFORMED. THE SAMPLE WAS TESTED WITH ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) REAGENT LOTS 061234 AND 061238 AND WITH IMMULITE 2000 TXP REAGENT LOT 442. THE SAMPLE WAS RUN NEAT AT N=3 ON BOTH INSTRUMENTS, AND WITH ALL REAGENT LOTS. ALL REPLICATES OF THE SAMPLE RECOVERED POSITIVE ON THE ADVIA CENTAUR XP FOR BOTH TOXO G LOTS 234 AND 238 AND NON-REACTIVE ON THE IMMULITE 2000 WITH TXP LOT 442. THE SAMPLE WAS THEN TREATED WITH HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) AND WAS RUN AT N=3 ON BOTH ADVIA CENTAUR XP TOXO G REAGENT LOTS. ALL REPLICATE RESULTS POST HBT AND NABT TREATMENT WERE STILL POSITIVE ON THE ADVIA CENTAUR XP FOR BOTH TOXO G REAGENT LOTS 234 AND 238 AND REPLICATED THE CUSTOMER'S OBSERVATIONS. RESULTS (IU/ML): ADVIA CENTAUR XP SAMPLE ID (B)(6): KIT LOT # 061234, 061238, REPLICATE 1 380.5 356.5, REPLICATE 2 379.4 370.8, REPLICATE 3 375.6 376.4. ADVIA CENTAUR XP SAMPLE ID (B)(6): KIT LOT # 061234 061238, REPLICATE 1 375.6 362.0, REPLICATE 2 385.9 374.3, REPLICATE 3 378.6 363.7. ADVIA CENTAUR XP SAMPLE ID (B)(6): KIT LOT # 061234 061238 REPLICATE 1 349.5 341.9, REPLICATE 2 352.5 340.6, REPLICATE 3 345.2 354.5. IMMULITE 2000 SAMPLE ID (B)(6): KIT LOT # 442, REPLICATE 1 <5.0, REPLICATE 2 <5.0, REPLICATE 3 <5.0. THE SIEMENS' SUMMARY RESULTS REPLICATED THE CUSTOMER'S OBSERVATIONS WITH THIS PATIENT SAMPLE AND INDICATE THAT THIS IS NEITHER AN ADVIA CENTAUR TOXO G LOT SPECIFIC ISSUE NOR A SITE/SYSTEM SPECIFIC ISSUE. THE INTERNAL STUDY RESULTS ARE INDICATIVE OF A SAMPLE SPECIFIC ISSUE AND DOES NOT CONFIRM A SIEMENS PRODUCT NON-CONFORMANCE. THE CALCULATED SPECIFICITY ON THIS ACCOUNT FOR TOXO G LOT 238 IS 695/696= 0.9985 X 100= 99.9%. THE RELATIVE SPECIFICITY ADVIA CENTAUR XP TXOG AS DESCRIBED IN THE INSTRUCTION FOR USE (IFU) 10629904_EN REV. AA, 2016-04 IS 99.6 %. THE CUSTOMER HAS NOT REPORTED ANY NEW INCIDENTS OF FALSE REACTIVE TOXO G RESULTS AND THIS ISSUE IS AN ISOLATED AND SAMPLE SPECIFIC INCIDENT. BASED ON THE AVAILABLE INFORMATION, THE ADVIA CENTAUR XP TOXOPLASMA G LOT 061238 IS PERFORMING AS INTENDED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. MDR 1219913-2019-00013 SUPPLEMENTAL REPORT 1 WAS FILED FOR THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. 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." MDR 1219913-2019-00013 WAS FILED FOR THE SAME EVENT.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULTS WERE OBTAINED ON TWO DIFFERENT DRAWS FROM THE SAME PATIENT. THE POSITIVE RESULTS WERE FOUND TO BE DISCORDANT WITH THE CURRENT RESULTS FROM AN ALTERNATE METHOD AND HISTORICAL NEGATIVE RESULTS. THE TOXO M RESULTS WERE ALWAYS 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
    98299 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 72148238 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1