BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 TOXOPLASMA IGG

    MDR report key: 1240871 · Received November 6, 2008

    Report

    Report Number
    2017183-2008-00049
    Event Type
    Other
    Date Received
    November 6, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LGD
    PMA / PMN Number
    K970227
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THERE WAS AN ISSUE WITH THE REAGENT LEVEL SENSING, WHICH HAS BEEN CORRECTED. THE CUSTOMER DECLINED FURTHER SERVICE ON THIS ISSUE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOWER THAN EXPECTED IMMULITE 2000 TOXOPLASMA IGG PT RESULT WAS OBTAINED ON A SAMPLE THAT WAS INITIALLY A HIGH POSITIVE. THIS SAMPLE WAS REPEATED AND IT REPEATED AS LOW RESULT. A FINAL REPEAT OF THE SAMPLE CONFIRMED THE POSITIVE TOXO IGG RESULT. THE INITIAL RESULT WAS RELEASED TO THE PHYSICIAN. PT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES, DUE TO THE DISCORDANT LOW TOXOPLASMA IGG ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 TOXOPLASMA IGG TOXOPLASMA IGG IMMUNOASSAY LGD SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 218

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR