BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3082512 · Received April 29, 2013

    Report

    Report Number
    1823260-2013-02598
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 11, 2013
    Report Date
    May 22, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED. INTERFERENCE TESTING WAS PERFORMED, AND NO MACRO-TSH INTERFERENCE WAS IDENTIFIED IN THE THREE PATIENT SAMPLES. THE SAMPLES WERE SENT TO ANOTHER LABORATORY AND TESTED WITH A SIEMENS CENTAUR ANALYZER. SAMPLE 1 COULD NOT BE ANALYZED DUE TO LACK OF SAMPLE VOLUME. THE ELEVATED TSH RESULTS WERE VERIFIED ON SAMPLES 2 AND 3. NO ISSUES WITH THE ELECSYS TSH REAGENT WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT ON THEIR E602 ANALYZER. THE PATIENT'S SAMPLES WERE RUN IN SAMPLE CUPS. THE PATIENT WAS GIVEN A THYROID-RELEASING HORMONE (TRH) STIMULATING TEST AND THE PATIENT'S TSH RESULTS WERE UNBELIEVABLY HIGH COMPARED TO THE FREE THYROXINE AND FREE TRIIODOTHYRONINE RESULTS. THE PATIENT'S RESULTS CAME FROM THREE SEPARATE BLOOD DRAWS. AT MINUTE ZERO OF THE TEST, THE PATIENT'S TSH RESULT WAS 105 UU/ML. AT MINUTE 20 OF THE TEST, THE PATIENT'S TSH RESULT WAS 341.5 UU/ML. AT MINUTE 60 OF THE TEST, THE PATIENT'S TSH RESULT WAS 251 UU/ML. THE PATIENT'S RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE TSH REAGENT LOT NUMBER WAS 171226 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE PATIENT'S SAMPLES WERE RETURNED FOR INVESTIGATION. THE SAMPLES WERE INVESTIGATED FOR INTERFERENCE TO THE FAB2 FRAGMENT. NO INTERFERENCE WAS IDENTIFIED IN THIS INVESTIGATION. THE CUSTOMER'S RESULTS WERE REPRODUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183662 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1