BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G)

    MDR report key: 9432164 · Received December 6, 2019

    Report

    Report Number
    1219913-2019-00267
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    February 7, 2019
    Report Date
    March 3, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED INITIAL MDR 1219913-2019-00267 ON DECEMBER 6, 2019. SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2019-00267 SUPPLEMENTAL REPORT 1 ON JANUARY 16, 2020. ADDITIONAL INFORMATION 02/26/2020: INVESTIGATION IS COMPLETE. CUSTOMER REPORTED AN INCREASE OF FALSE REACTIVE PATIENT RESULTS WITH ADVIA CENTAUR XP TOXOPLASMA IGG (TOXO G) REAGENT LOTS 061238, 242, 244 AND 246 AND TOXOPLASMA IGM (TOXO M) REAGENT LOTS 080318, 322 AND 326 VERSUS AN ALTERNATE TESTING METHOD. FROM THE PATIENT DATA PROVIDED IT WAS NOTED THAT THE CUSTOMER REPEATED TOXO G AND TOXO M SAMPLES THAT HAD RESULTS OF NONREACTIVE AND EQUIVOCAL PRODUCED FROM THE CENTAUR XP SYSTEM. THE CUSTOMER CENTRIFUGED THE SAMPLES AT 2200G FOR 10 MINUTES PRIOR TO TESTING. CALIBRATION AND QUALITY CONTROL DATA WERE NOT PROVIDED. IN CONCLUSION, THERE WAS ONLY ONE PATIENT SAMPLE THAT HAD A FALSE REACTIVE TOXO G RESULT WHEN TESTED ON ADVIA CENTAUR XP WITH LOT 238 VERSUS THE ALTERNATE METHOD AND A DIFFERENT PATIENT SAMPLE WITH FALSE REACTIVE TOXO M RESULT WHEN TESTED ON ADVIA CENTAUR XP WITH LOT 322 VERSUS THE ALTERNATE METHOD. BASED ON ADVIA CENTAUR TOXO G INSTRUCTIONS FOR USE (IFU) 10629904_EN REV. AB, 2019-08 AND ON THE ADVIA CENTAUR TOXO M IFU 10629906_EN REV. V, 2019-08 PREPARING THE SAMPLES SECTIONS, "SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER. REMOVE PARTICULATES BY FILTRATION OR CENTRIFUGATION AT 1000 X G FOR 10-15 MINUTES." PREANALYTIC FACTORS AND/OR SAMPLE HANDLING LEADING TO PARTICULATE MATTER CANNOT BE RULED OUT AS THE CAUSATIVE AGENT FOR THE FALSE REACTIVE RESULTS. THERE WAS NOT SUFFICIENT SAMPLE(S) VOLUME AVAILABLE TO BE SENT TO SIEMENS FOR FURTHER EVALUATION, AND HETEROPHILIC BLOCKING TUBE (HBT) AND/OR NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT) TESTING WAS NOT PERFORMED AT THE CUSTOMER'S SITE. CUSTOMER HAS NOT BEEN ABLE TO PROVIDE INFORMATION NEEDED TO CALCULATE THE RELATIVE SPECIFICITY ON THIS ACCOUNT FOR TOXO G AND TOXO M ASSAYS. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED WITH ADVIA CENTAUR XP TOXOPLASMA IGG AND ADVIA CENTAUR XP TOXOPLASMA IGM . NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 1219913-2019-00267 ON DECEMBER 6, 2019. ADDITIONAL INFORMATION 01/14/2020: THE CUSTOMER USES THE ADVIA CENTAUR SYSTEMS TOXO M AND TOXO G INSTRUCTIONS FOR USE INTERPRETATIONS. NON-REACTIVE EQUIVOCAL REACTIVE TOXO M <0.9 INDEX 0.9 -0.99 INDEX >/= 1.0 INDEX TOXO G <6 .4 IU/ML 6.4 -9.9 IU/ML >/=10 IU/ML THE CUSTOMER REPEATS REACTIVE AND EQUIVOCAL PATIENTS WITH AN ALTERNATE METHOD FOR CONFIRMATION. NO PATIENT INFORMATION IS AVAILABLE; NO REMAINING VOLUME OF PATIENT SAMPLE FOR SIEMENS TO TEST; INSTRUMENT SERVICE/CHECK HAS NOT BEEN PERFORMED. SIEMENS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE TOXO G INSTRUCTIONS FOR USE 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. 8 AS WITH ALL IN VITRO DIAGNOSTIC ASSAYS, EACH LABORATORY SHOULD DETERMINE ITS OWN REFERENCE RANGE(S) FOR THE DIAGNOSTIC EVALUATION OF PATIENT RESULTS." "HUMAN ANTI-MOUSE ANTIBODIES (HAMA) OR HETEROPHILE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM INDIVIDUALS EXPOSED TO MOUSE OR ANIMAL IMMUNOGLOBULINS FROM NATURAL SOURCES OR AS PART OF DISEASE THERAPIES. THESE ANTIBODIES MAY INTERFERE WITH THE ADVIA CENTAUR TOXO G ASSAY AND GIVE FALSELY POSITIVE OR FALSELY NEGATIVE RESULTS. 10 THESE SAMPLES SHOULD NOT BE TESTED." "HUMAN ANTI-MOUSE ANTIBODIES (HAMA) OR HETEROPHILE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM INDIVIDUALS EXPOSED TO MOUSE OR ANIMAL IMMUNOGLOBULINS FROM NATURAL SOURCES OR AS PART OF DISEASE THERAPIES. THESE ANTIBODIES MAY INTERFERE WITH THE ADVIA CENTAUR TOXO G ASSAY AND GIVE FALSELY POSITIVE OR FALSELY NEGATIVE RESULTS. 10 THESE SAMPLES SHOULD NOT BE TESTED."

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A FALSE POSITIVE RESULT WITH ADVIA CENTAUR XP TOXOPLASMA IGG (TOXO G). THE RESULT WAS PROVIDED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS TESTED WITH AN ALTERNATE METHOD AND A NEGATIVE RESULT WAS OBTAINED. THE CUSTOMER BELIEVES THE NEGATIVE RESULT TO BE CORRECT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXO G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215994 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) TOXOPLASMA GONDII IMMUNOASSAY, LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 05337238 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1