BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMUNOCHEMISTRY ANALYZER -JJE

    MDR report key: 1502917 · Received September 18, 2009

    Report

    Report Number
    1823260-2009-06223
    Event Type
    Malfunction
    Date Received
    September 18, 2009
    Date of Event
    August 24, 2009
    Report Date
    February 3, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TWO SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. THE NORMAL ELECSYS FREE T4 RESULTS WERE LOWER THAN THE COMPETITOR ASSAY (IMMULITE), BUT BOTH RESULTS WERE WITHIN THE REFERENCE RANGE. FURTHER INTERFERENCE ANALYSIS EXCLUDED RUTHENIUM INTERFERENCE. A DIFFERENT FREE T4 COMPETITOR ASSAY (CENTAUR) GENERATED RESULTS WHICH WERE MUCH HIGHER THAN THE ELECSYS AND IMMULITE RESULTS. THE FREE T3 RESULT (FROM AN ELECSYS AT ANOTHER LAB) COULD NOT BE DUPLICATED. BOTH SAMPLES RECOVERED WITHIN THE REFERENCE RANGE FOR FREE T3 DURING THE INVESTIGATION. INTERFERENCE ANALYSIS EXCLUDED RUTHENIUM INTERFERENCE FOR FREE T3 ALSO. THE INVESTIGATION CONCLUDED THE ELEVATED ELECSYS FREE T4 RESULTS SHOULD BE RELIABLE. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED DISCORDANT FREE T4 RESULTS AND REQUESTED INTERFERENCE INVESTIGATION FOR FREE T4 ASSAY. PT IS EUTHYROID AND NOT PRESENTLY TAKING ANY THYROID MEDICATION. CUSTOMER PROVIDED THE FOLLOWING FREE T4 RESULTS (USING A SERUM SAMPLE): INITIAL FREE T4 RESULT 13.5 (TSH=GREATER THAN 100 MU/L), REPEATED ON IMMULITE ANALYZER GAVE 23.6 (TSH=GREATER 75 MU/L) AND REPEATED AT ANOTHER LAB GAVE 34.2 PMOL/L (TSH=GREATER THAN 100 MU/L). ACCORDING TO THE CUSTOMER, CONSEQUENCES TO THE PT ARE UNK, NO ALLEGATION OF DEATH OR SERIOUS INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR