BEUDAMED
    FDA Adverse Event Other Summary report: N

    EVOLIS MICROPLATE SYSTEM

    MDR report key: 2261442 · Received September 21, 2011

    Report

    Report Number
    3022521-2011-00003
    Event Type
    Other
    Date Received
    September 21, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 21, 2011
    Manufacturer
    BIO-RAD LABORATORIES, INC.
    Product Code
    LOL
    PMA / PMN Number
    K092353
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CUSTOMER CONTACTED THE BIO-RAD LABORATORIES TECHNICAL SUPPORT DEPARTMENT TO REQUEST HELP IN INTERPRETING A RESULT FROM A PT SAMPLE WHEN RUNNING THE BIO-RAD TOXOPLASMA IGG EIA ASSAY, ON THE EVOLIS MICROPLATE SYSTEM. THE EVOLIS IS A 4-PLATE SELF-CONTAINED MICROPLATE PROCESSOR SYSTEM DESIGNED FOR USE WITH EIA ASSAYS. THE CUSTOMER REPORTED THE PT SAMPLE RESULT VALUE WAS HIGHER THAN THE TOXOPLASMA IGG CALIBRATOR 1 VALUE FOR THE ASSAY BUT THE RESULT REPORTED WAS NEGATIVE. THE CUSTOMER STATED THAT A PREVIOUS PT SAMPLE VALUE WAS HIGHER THAN THE TOXOPLASMA IGG CALIBRATOR 1 VALVE BUT THE REPORTED RESULT WAS POSITIVE. TECHNICAL SUPPORT REVIEWED THE DATA SENT BY THE CUSTOMER AND DISCOVERED THAT THE CUSTOMER HAD ENTERED INCORRECT VALUES FOR THE MINIMUM AND MAXIMUM POSITIVE CONTROL TOXOPLASMA IGG CALIBRATOR 1, AND TOXOPLASMA IGG CALIBRATOR 2. THE CUSTOMER ENTERED THE INDEX VALUES INSTEAD OF THE IU/ML AS STATED IN THE EVOLIS MATRM FOR THE TOXOPLASMA IGG EIA ASSAY. TECHNICAL SUPPORT INFORMED THE CUSTOMER THE VALUES ENTERED WERE INCORRECT AND INSTRUCTED THE CUSTOMER TO FOLLOW THE MATRM; WHICH TELLS THE CUSTOMER WHAT SHOULD BE ENTERED. TECHNICAL SUPPORT REQUESTED PREVIOUS RUN DATA FOR REVIEW TO SEE IF THE ERROR OCCURRED IN PREVIOUS RUNS. THE REVIEW OF THE DATA SHOWED 4 PT SAMPLES WHICH SHOULD HAVE BEEN REPORTED AS POSITIVE WERE REPORTED AS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVOLIS MICROPLATE SYSTEM 4 PS (FOUR PLATE SYSTEM) LOL BIO-RAD LABORATORIES, INC. EVOLIS

    Patients

    Seq Age Sex Outcome Treatment
    1