BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 4546958 · Received February 25, 2015

    Report

    Report Number
    1219913-2015-00036
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    January 23, 2015
    Report Date
    February 6, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K012183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) TEST RESULT WHEN COMPARED TO THE NEGATIVE ALTERNATE LABORATORY TEST METHOD RESULTS IS UNKNOWN. THE CUSTOMER PERFORMED ADDITIONAL NABT (NON-SPECIFIC ANTIBODY BLOCKING TUBE) TESTING FOR INTERFERENCE AND THE RESULT WAS POSITIVE. NO CONCLUSION CAN BE DRAWN. SIEMENS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER INVESTIGATION. CUSTOMER'S ADDITIONAL NABT TEST RESULTS: REAGENT LOT # 061203, TOXOPLASMA G (TOXO G) WITHOUT NABT - 88.4 UI/ML (POSITIVE). TOXOPLASMA G (TOXO G) WITH NABT - 87.7 UI/ML (POSITIVE).

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2015-00036 ON 02/25/2015 FOR A FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT OBTAINED ON A PATIENT SAMPLE. ON 03/27/2015 ADDITIONAL INFORMATION: THE PATIENT SAMPLE WAS RECEIVED FOR FURTHER TESTING AND INVESTIGATION. THE ADVIA CENTAUR TOXOPLASMA G (TOXO G) SAMPLE TEST RESULTS WERE POSITIVE WITH TWO DIFFERENT REAGENT LOTS AND NEGATIVE WHEN TESTED ON AN ALTERNATE TOXOPLASMA G TEST METHOD. THE PATIENT SAMPLE WITH A HETEROPHILIC BLOCK TUBE (HBT) WAS POSITIVE, INDICATING THERE IS NOT A HETEROPHILIC INTERFERENCE. THE CAUSE FOR THE FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT IS UNKNOWN. THE CUSTOMER RUNS APPROXIMATELY 1200 TOXOPLASMA G (TOXO G) SAMPLES PER MONTH AND HAS OBSERVED ONE DISCORDANT ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT. THE APPROXIMATE SPECIFICITY 1199/1200 = 99.91% AND MEETS THE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) INSTRUCTION FOR USE (IFU) RELATIVE SPECIFICITY CLAIM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION IS REQUIRED. SIEMENS TEST RESULTS: ADVIA CENTAUR TOXG LOT 061202; MEAN RESULT = 79.7 IU/ML (POSITIVE). TOXG LOT 061205; MEAN RESULT = 74.7 IU/ML (POSITIVE). ALTERNATE TOXO G TEST METHOD RESULT: MEAN RESULT = <5.00 IU/ML (NEGATIVE). HETEROPHILIC BLOCKING TUBE (HBT): TOXG LOT 061202; MEAN RESULT = 82.27 IU/ML (POSITIVE).

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND THE RESULT WAS QUESTIONED BY THE PHYSICIAN. THE PATIENT'S ADVIA CENTAUR XP TOXOPLASMA G RESULT FROM (B)(6) 2014 HAD BEEN POSITIVE. THE CUSTOMER PERFORMED ADDITIONAL TESTING WITH THREE OTHER ALTERNATE TOXOPLASMA G TEST METHODS AND THE RESULTS WERE NEGATIVE. THE PATIENT SAMPLE FROM (B)(6) 2014 WAS REPEATED AND THE ADVIA CENTAUR XP TOXOPLASMA G RESULT WAS POSITIVE. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TOXOPLASMA G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131885 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 061202

    Patients

    Seq Age Sex Outcome Treatment
    1