BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3800023 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03292
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    October 16, 2013
    Report Date
    June 10, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE SPECIFIC PART NUMBER INVOLVED IN THIS EVENT WAS REQUESTED BUT NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE FOUR PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. ALL FOUR SAMPLES WERE FOUND TO BE REACTIVE FOR TOXG, CONFIRMING THE CUSTOMER'S OBSERVATIONS. THE CUSTOMER'S RESULTS WERE ALSO CONFIRMED USING A VALIDATED NEUTRALIZATION ASSAY. THE REAGENT WORKED TO SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXG) RESULTS FOR FOUR PATIENTS ON THEIR E-MODULE. THE CUSTOMER STATED THE SAMPLES WERE DRAWN APPROXIMATELY (B)(6) 2013. THE EXACT DRAW DATES WERE REQUESTED BUT NOT PROVIDED. THE CUSTOMER STATED THE RESULTS FROM THE E-MODULE WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE THEN REPEATED ON AN ABBOTT ARCHITECT ANALYZER. THE FIRST PATIENT'S INITIAL TOXG RESULT WAS 29.54 UI/ML AND WAS POSITIVE. THE REPEAT RESULT WAS 1.4 UI/ML AND IT WAS NEGATIVE. THE SECOND PATIENT'S INITIAL TOXG RESULT WAS 25.62 UI/ML AND WAS POSITIVE. THE REPEAT RESULT WAS 1.4 UI/ML AND IT WAS NEGATIVE. THE THIRD PATIENT'S INITIAL TOXG RESULT WAS 32.37 UI/ML AND WAS POSITIVE. THE REPEAT RESULT WAS 1.5 UI/ML AND IT WAS NEGATIVE. THE FOURTH PATIENT'S INITIAL TOXG RESULT WAS 43.5 UI/ML AND WAS POSITIVE. THE REPEAT RESULT WAS 1.0 UI/ML AND IT WAS NEGATIVE. THERE WERE NO ADVERSE EVENTS. THE TOXG REAGENT LOT NUMBER WAS 172037-02. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279428 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1