BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 7047926 · Received November 21, 2017

    Report

    Report Number
    1823260-2017-02703
    Event Type
    Malfunction
    Date Received
    November 21, 2017
    Date of Event
    November 6, 2017
    Report Date
    January 29, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. THREE OF THE PATIENT SAMPLES WERE SUBMITTED FOR INVESTIGATION. THE CUSTOMER'S TSH RESULTS WERE CONFIRMED. UPON FURTHER INVESTIGATION, NO INTERFERING FACTORS WERE DETECTED IN THE SAMPLES AND A GENERAL REAGENT ISSUE WAS NOT FOUND. ASSAYS FROM DIFFERENT VENDORS MAY GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUP OF THE ASSAYS, THE ANTIBODIES USED, AND DIFFERENCES IN REFERENCE MATERIALS/METHODS AND THE STANDARDIZATION METHODOLOGY USED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING IN SEPTEMBER, A PATIENT INFORMED THE LABORATORY ABOUT A DISCREPANCY. THE SPECIFIC DATES OF TESTING WERE NOT PROVIDED. THE TSH RESULT WAS 11 MUI/L AND THE REPEAT RESULT WAS 11 MUI/L. THE RESULT FROM AN ABBOTT ARCHITECT WAS 4.77 MUI/L. THIS PATIENT CAME BACK TO THE LAB THE (B)(6) 2017 AND THE RESULT WAS AT 1.00 MUI/L. THIS PATIENT WAS UNDER LEVOTHYROX BUT NOT TAKEN THE DAY OF THE BLOOD DRAW. TWO OTHERS PATIENTS HAD A SIMILAR ISSUE. THE SPECIFIC DATES OF TESTING WERE NOT PROVIDED. PATIENT A: TSH RESULT WAS 8.29 MUI/L AND ARCHITECT RESULT WAS 2.40 MUI/L. PATIENT B: TSH RESULT WAS 6.00 MUI/L AND ARCHITECT RESULT WAS 2.80 MUI/L. THE CUSTOMER DECIDED TO REPEAT SOME OTHER SAMPLES WITH ABNORMAL RESULTS. OF THIS DATA, ONLY THE RESULTS FOR TWO SAMPLES WERE DISCREPANT. PATIENT 1: TAKING LEVOTHYROX BUT IT NOT TAKEN DURING THE DAY OF THE BLOOD DRAW. ON (B)(6) 2017, THE TSH RESULT WAS 5.82 MUI/L AND THE REPEAT RESULT ON (B)(6) 2017 WAS 3.69 MUI/L. PATIENT 2: ON (B)(6) 2017, THE TSH RESULT WAS 7.03 MUI/L AND THE REPEAT RESULT ON (B)(6) 2017 WAS 4.41 MUI/L.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE HIGH ELECSYS TSH ASSAY RESULTS FOR THREE PATIENT SAMPLES WHEN COMPARED TO THE RESULTS FROM AN ABBOTT ANALYZER. FOR EACH OF THE PATIENTS, THE RESULT FROM THE COBAS 8000 E801 MODULE WAS AROUND 7 MUI/L BUT THE RESULT WAS AROUND 4 MUI/ML WITH THE ABBOTT METHOD. THE SAMPLES WERE REPEATED IN OTHER LABORATORIES USING THE ROCHE METHOD AND THE RESULTS WERE AROUND 7 MUI/L. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE SERIAL NUMBER OF THE COBAS 8000 E801 MODULE WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829847 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 226387

    Patients

    Seq Age Sex Outcome Treatment
    1