BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6185682 · Received December 19, 2016

    Report

    Report Number
    1823260-2016-01990
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER IS COMPLAINING OF QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS TSH ASSAY ON TWO DIFFERENT COBAS 6000 E 601 MODULE ANALYZERS WITH UNKNOWN SERIAL NUMBERS. A SAMPLE WAS TESTED ON (B)(6) 2016 ON A BECKMAN COULTER ANALYZER WITH A TSH OF 2.011 UIU/ML. A SECOND SAMPLE WAS TESTED ON (B)(6) 2016 ON A ROCHE E411 ANALYZER WITH A TSH OF 1.83 UIU/ML. A THIRD SAMPLE WAS TESTED ON (B)(6) 2016 ON 2 DIFFERENT E 601 ANALYZERS WITH RESULTS OF 19.49 AND 20.00 UIU/ML. INFORMATION FOR A SECOND LOT OF TSH REAGENT WAS PROVIDED: LOT NUMBER 179010 WITH AN EXPIRATION DATE OF 07/31/2017. IT IS UNKNOWN WHICH LOT NUMBER OF REAGENT PRODUCED WHICH RESULT. IT IS UNKNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. CALIBRATION SIGNALS FOR THE ANALYZER RUNNING LOT NUMBER 185522 OF THE TSH REAGENT WERE HIGH. CALIBRATION SIGNALS FOR THE ANALYZER RUNNING LOT NUMBER 179010 WERE OK. QUALITY CONTROLS FOR BOTH ANALYZERS WERE OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838533 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 185522

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR