BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 3692717 · Received March 21, 2014

    Report

    Report Number
    1823260-2014-02015
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY WERE RECEIVING QUESTIONABLE FREE TRIIODOTHYRONINE (FT3) RESULTS FOR ONE PATIENT ON THEIR ELECSYS 2010 ANALYZER. IT WAS SUSPECTED THE QUESTIONABLE RESULTS WERE DUE TO A NON-SPECIFIC REACTION. THE CUSTOMER RETURNED ONE PATIENT SAMPLE THAT WAS TAKEN ON (B)(6) 2014 FOR INVESTIGATION. THE SAMPLE WAS TESTED ON THE 2010 ANALYZER WITH THE SECOND GENERATION FT3 REAGENT AND THE RESULT WAS 4.28 PG/ML. THE FT3 REAGENT LOT NUMBER WAS 173147. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE SAMPLE WAS TESTED ON THE 2010 ANALYZER WITH THE THIRD GENERATION FT3 REAGENT AND THE RESULT WAS 4.15 PG/ML. THE FT3 REAGENT LOT NUMBER WAS 172621. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE SAMPLE WAS THEN TESTED ON A CENTAUR ANALYZER AND THE RESULT WAS 1.5 PG/ML. THESE RESULTS WERE SUBMITTED TO THE PHYSICIAN. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. A ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. A PEG PRECIPITATION, A PROTEIN PRECIPITATION, AND HPLC ANALYSIS WERE PERFORMED AND NO CONCLUSIONS COULD BE DRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168420 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1