BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOXO IGG, IGG ANTIBODIES TO TOXOPLASMA GONDII

    MDR report key: 2103461 · Received May 26, 2011

    Report

    Report Number
    1823260-2011-02801
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 18, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DIFFERENT SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE CUSTOMER'S ALLEGATION OF DIFFERENT RESULTS BETWEEN ROCHE AND COMPETITOR ASSAYS WAS VERIFIED. FURTHER INVESTIGATION REVEALED THAT THE POSITIVE/REACTIVE RESULT WAS CORRECT FOR BOTH SAMPLES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE TOXOPLASMA IGG RESULTS FOR ONE PATIENT FROM THE COBAS E411 DISK ANALYZER SERIAL NUMBER (B)(4). ALL RESULTS ARE IN IU/ML. ON (B)(6) 2011, THE FIRST SAMPLE FROM THE PATIENT WAS TESTED ON THE VIDAS ANALYZER AND GENERATED A NEGATIVE RESULT. ON (B)(6) 2011, A SECOND SAMPLE FROM THE PATIENT WAS TESTED ON THE E411 ANALYZER AND THE RESULT WAS 53.55 (POSITIVE). ON (B)(6) 2011, THE USER REPEATED TESTING OF BOTH SAMPLES ON THE E411 ANALYZER AND THE RESULT FOR SAMPLE 1 WAS 59.54 (POSITIVE) AND FOR SAMPLE 2 WAS 56.88 (POSITIVE). THE SAMPLES WERE SENT TO ANOTHER LAB TO FOR AVIDITY ASSAYS BUT THE TESTS WERE NOT PERFORMED BECAUSE THE TOXOPLASMA IGG RESULTS WERE NEGATIVE. THE POSITIVE RESULTS WERE REPORTED FOR THE SAMPLES. THE PATIENT "START TO DO TREATMENT CONCERNING THE TOXO", BUT THE DOCTOR STOPPED THE TREATMENT AFTER THE FIRST INGESTION. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE.

    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
    1 036 YR