BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOXO IGG, IGG ANTIBODIES TO TOXOPLASMA GONDII

    MDR report key: 2121528 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03205
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 11, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K073501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IN QUESTION WAS PROVIDED FOR INVESTIGATION AND THE CUSTOMER'S ALLEGATION OF DIFFERING RESULTS BETWEEN ROCHE AND COMPETITOR ASSAYS WERE VERIFIED. FURTHER INVESTIGATION REVEALED THAT THE POSITIVE ROCHE RESULT WAS CORRECT FOR THIS SAMPLE.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TOXOPLASMA IGG RESULTS FOR ONE PATIENT SAMPLE FROM THE ANALYTICAL E MODULE ANALYZER (B)(4). THE RESULTS FROM THE ANALYTICAL E MODULE WERE 46.8 AND 48 IU/ML WHICH WERE CONSIDERED POSITIVE/REACTIVE. THE RESULT FROM THE VIDAS ANALYZER WAS 3 UI/ML WHICH WAS CONSIDERED NEGATIVE. THE RESULT FROM THE ACCESS ANALYZER WAS NEGATIVE. NO SPECIFIC DATA WAS PROVIDED FOR THIS RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOXO IGG, IGG ANTIBODIES TO TOXOPLASMA GONDII ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII LGD ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 033 YR