BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA M (TOXO M)

    MDR report key: 3451705 · Received November 6, 2013

    Report

    Report Number
    1219913-2013-00263
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Date of Event
    May 15, 2013
    Report Date
    October 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LGD
    PMA / PMN Number
    K010755
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TOXOPLASMA M RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "PATIENT SPECIMENS COLLECTED VERY EARLY DURING THE ACUTE PHASE OF INFECTION MAY CONTAIN TOXOPLASMA IGM LEVELS BELOW THE CUTOFF OF THE ADVIA CENTAUR TOXO M ASSAY. ADDITIONALLY, DIAGNOSIS OF A RECENT INFECTION SHOULD NOT BE MADE BASED ON A SINGLE SAMPLING BECAUSE IGM ANTIBODIES TO T. GONDII MAY PERSIST IN SERUM MANY MONTHS AFTER INFECTION.8 THE PRESENCE OF IGM ANTIBODIES TO T. GONDII IS NOT DIAGNOSTIC FOR RECENT INFECTION." THE IFU STATES IN THE INTENDED USE SECTION: "THE ADVIA CENTAUR TOXO M ASSAY IS USED TO MEASURE IGM ANTIBODY AGAINST T. GONDII WHICH IS PRESUMPTIVE OF AN ACUTE, RECENT, OR REACTIVATED TOXOPLASMA INFECTION. ANY MEASUREMENT OF IGM ANTIBODY TO T. GONDII MUST BE PERFORMED IN CONJUNCTION WITH THE DETERMINATION OF IGG ANTIBODY TO T. GONDII."

    Description of Event or Problem · 1

    A NEGATIVE ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO THE FOLLOW-UP TESTING. THE RESULTS WERE POSITIVE FOR THE FOLLOW-UP TESTING. REPEAT TESTING WAS PERFORMED FOR THE PATIENT SAMPLE THAT HAD THE NEGATIVE RESULT. THE REPEAT RESULT WAS POSITIVE. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TOXO M RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573216 ADVIA CENTAUR XP TOXOPLASMA M (TOXO M) TOXO M IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 231

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR