BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3851676 · Received June 5, 2014

    Report

    Report Number
    1823260-2014-04052
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    February 11, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOUR RETURNED SAMPLES WERE FURTHER INVESTIGATED. FOR TWO OF THE SAMPLES, AN INTERFERING FACTOR TO RUTHENIUM WAS IDENTIFIED. THIS INTERFERENCE IS COVERED IN THE PACKAGE INSERT. FOR THE OTHER TWO SAMPLES, NO INTERFERING FACTORS WERE IDENTIFIED. THE PATIENT REPORTED IN THE INITIAL MEDWATCH DID NOT SHOW AN INTERFERING FACTOR. A ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    FOUR PATIENT SAMPLES WERE RETURNED FOR INVESTIGATION. THE CUSTOMER'S FT3 RESULTS WERE REPRODUCED. ONE OF THE SAMPLES WAS TESTED FOR INTERFERENCE, AND NO INTERFERENCE TO STREPTAVIDIN WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE FREE TRIIODOTHYRONINE (FT3) AND FREE THYROXINE RESULTS COMPARED TO TRIIODOTHYRONINE (T3) AND THYROXINE ON THEIR E602 ANALYZER. THE CUSTOMER PROVIDED DATA FOR THREE SAMPLES, ONE OF WHICH HAD DISCREPANT FT3 AND T3 RESULTS. THE PATIENT'S FT3 RESULT WAS 22.61 PMOL/L. THE PATIENT'S T3 RESULT WAS 2.18, THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER ANY RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. INFORMATION ON WHETHER THE PATIENT WAS HARMED BY ANY ACTION TAKEN WAS REQUESTED BUT NOT PROVIDED. THE FT3 REAGENT LOT NUMBER WAS 175509-01. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE T3 REAGENT LOT NUMBER WAS 175511-01. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328929 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1