BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOXO IGG, IGG ANTIBODIES TO TOXOPLASMA GONDII

    MDR report key: 2143175 · Received June 28, 2011

    Report

    Report Number
    1823260-2011-03497
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 17, 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
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THE POSITIVE (B)(4) IGG RESULT WAS ACCURATE. FURTHER TESTING, INCLUDING A NEUTRALIZATION (CONFIRMATORY) ASSAY, CONFIRMED THE (B)(4) IGG RESULTS. SINCE THE (B)(4) RESULT WAS CONFIRMED BY THE INVESTIGATION, MEDICAL RISK DUE TO THE (B)(4) RESULT SEEMS UNLIKELY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE TOXOPLASMA IGG RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON A MODULAR E MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 15.87 UI/ML (POSITIVE). THE TOXOPLASMA IGM RESULT WAS 0.890 COI (BORDERLINE). THE TOXOPLASMA IGG RESULT WHEN TESTED USING A COMPETITIOR SYSTEM, IFI IGG BIOMERIEUX, WAS <10 UI/ML (REFERENCE RANGE 10). THE TOXOPLASMA IGM RESULT WAS <40 TITER (REFERENCE RANGE 40). THE TOXOPLASMA IGG RESULT WHEN TESTED USING ANOTHER COMPETITOR SYSTEM, VIDAS IGG BIOMERIEUX, WAS 0 UI/ML (REFERENCE RANGE 4-8). THE TOXOPLASMA IGA RESULT, WHEN TESTED USING PLATELIA EIA BIORAD, WAS 0.3 COI (REFERENCE RANGE 0.8-1.0). IT IS UNKNOWN WHICH RESULTS WERE REPORTED OUTSIDE THE LABORATORY. NO ADVERSE EVENTS WERE REPORTED.

    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 16020601

    Patients

    Seq Age Sex Outcome Treatment
    1 057 YR