BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 6767286 · Received August 4, 2017

    Report

    Report Number
    1219913-2017-00170
    Event Type
    Malfunction
    Date Received
    August 4, 2017
    Date of Event
    June 12, 2017
    Report Date
    September 27, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    UDI-DI
    00630414208459
    PMA / PMN Number
    K102681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00170 ON AUGUST 04, 2017. 09/15/2017 ADDITIONAL INFORMATION: SIEMENS RECEIVED TWO PATIENT SAMPLES WITH <500 UL VOLUME FOR FURTHER TESTING AND INVESTIGATION. DUE TO THE SAMPLE VOLUME, THE SAMPLES WERE TESTED N=1 WITH LOT 061224 AND LOT 061221. THE RESULTS WERE POSITIVE. THE PATIENT SAMPLES HAD INSUFFICIENT VOLUME FOR TESTING ON THE IMMULITE 2000 PLATFORM AND HBT (HETEROPHILIC BLOCKING TUBE) TESTING. RESULTS ((UI/ML): SAMPLE, LOT 061224, LOT 061221, SAMPLE 1 ((B)(6)), 127.6, 129, SAMPLE 2 ((B)(6)), 131.6, 118.6. THE CAUSE OF THE POSITIVE RESULTS WITH SAMPLES FROM THIS PATIENT WHEN USING THE ADVIA CENTAUR XP TOXOPLASMA G ASSAY CANNOT BE DETERMINED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TOXOPLASMA G (TOXO G) RESULTS IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLE FOR FURTHER TESTING AND INVESTIGATION. 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." THE IFU STATES IN THE INTERPRETATIONS FOR TOXOPLASMA GONDII SEROLOGY RESULTS TABLE: "ANTI-T. GONDII IGG RESULT : POSITIVE. ANTI-T. GONDII IGM: NEGATIVE. RESULT INTERPRETATION: FROM THESE RESULTS, IT CANNOT BE DETERMINED WHETHER THE PATIENT IS OR IS NOT UNDERGOING A REACTIVATED T. GONDII INFECTION. IT APPEARS THAT THE PATIENT HAS BEEN PREVIOUSLY INFECTED WITH T. GONDII. INFECTION MAY HAVE OCCURRED MORE THAN ONE YEAR AGO. IF THE INDIVIDUAL HAS NOT PREVIOUSLY TESTED POSITIVE FOR T. GONDII ANTIBODIES, CONFIRM THE RESULT WITH A REFERENCE LABORATORY WITH EXPERIENCE IN THE DIAGNOSIS OF TOXOPLASMOSIS."

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN AND WAS QUESTIONED. THE PATIENT SAMPLE WAS RUN ON TWO ALTERNATE METHODS AND THE RESULTS WERE NEGATIVE. THE PATIENT SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR FURTHER TESTING AND THE RESULTS WERE NEGATIVE. A CORRECTED REPORT WAS ISSUED. A SECOND COLLECTION FROM THE SAME PATIENT FROM (B)(6) 2017 WAS TESTED ON THE ADVIA CENTAUR XPT, ON TWO ALTERNATE METHODS AND THE AGGLUTINATION METHOD. THE TOXOPLASMA G RESULT WAS POSITIVE ON THE ADVIA CENTAUR XPT AND NEGATIVE ON THE OTHER METHODS. BOTH SAMPLES WERE TESTED ON THE ADVIA CENTAUR XPT TOXO IGM ASSAY AND THE RESULTS WERE NEGATIVE. THE PATIENT IS PREGNANT THE PATIENT RECEIVED ANTIBIOTICS (ROVAMICIN). THE MEDICATION WAS SUSPENDED AFTER THE NEGATIVE RESULT WAS OBTAINED. 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
    549362 ADVIA CENTAUR XPT TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA GONDII IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 221 00630414208459

    Patients

    Seq Age Sex Outcome Treatment
    1