BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY

    MDR report key: 1820753 · Received August 27, 2010

    Report

    Report Number
    1219913-2010-00098
    Event Type
    Other
    Date Received
    August 27, 2010
    Date of Event
    July 27, 2010
    Report Date
    August 10, 2010
    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 FALSE POSITIVE TOXOPLASMA G RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    POSITIVE ADVIA CENTAUR XP TOXOPLASMA G RESULTS WERE OBTAINED ON A PT SAMPLE WHEN COMPARED TO OTHER METHODS. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSE POSITIVE TOXOPLASMA G RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP TOXOPLASMA G (TOXO G) ASSAY TOXOPLASMA G (TOXO G) IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 172

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR