BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 3284905 · Received August 14, 2013

    Report

    Report Number
    1823260-2013-04841
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    July 24, 2013
    Report Date
    September 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE CONFIRMED AND DEEMED TO HAVE BEEN CORRECT. THIS WAS CONFIRMED USING A VALIDATED NEUTRALIZATION TEST.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE IGG ANTIBODIES TO TOXOPLASMA GONDII (TOXOG) RESULT FOR ONE PATIENT ON THEIR E601 ANALYZER. THE PATIENT'S INITIAL TOXOG RESULT WAS 42.18 IU/ML, WHICH WAS CONSIDERED REACTIVE, AND IT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS THEN TESTED ON A LIAISON ANALYZER AND THE RESULT WAS 5 U.I./ML, WHICH WAS CONSIDERED NONREACTIVE. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE TOXOG REAGENT LOT NUMBER WAS 171242. THE EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390473 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER LGD ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 039 YR