BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4704811 · Received April 18, 2015

    Report

    Report Number
    1823260-2015-03091
    Event Type
    Malfunction
    Date Received
    April 18, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 17, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    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).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR TWO PATIENT SAMPLES TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). OF THE TWO SAMPLES, ONE HAD ERRONEOUS RESULTS FOR FT3 AND THE OTHER ONE HAD ERRONEOUS TSH RESULTS. IT WAS ASKED, BUT THE DATE OF THE EVENT IS NOT KNOWN. THIS MEDWATCH WILL COVER THE SECOND SAMPLE TESTED FOR TSH. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION REFERRING TO THE FIRST SAMPLE, WHICH WAS TESTED FOR FT3. THE SAMPLE WAS INITIALLY TESTED AT THE CUSTOMER SITE ON AN E602 ANALYZER AND THEN REPEATED ON A CENTAUR ANALYZER. DURING INVESTIGATIONS, THE PATIENT SAMPLE WAS TESTED ON A COBAS 8000 ANALYZER AND AN E411 ANALYZER. REFER TO THE ATTACHMENT FOR THE SPECIFIC PATIENT RESULT VALUES. IT WAS ASKED, BUT IT IS UNKNOWN WHICH PATIENT RESULTS, IF ANY, WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE INVESTIGATION WERE PROVIDED TO THE CUSTOMER. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE PATIENT WAS ADVERSELY AFFECTED. NO ADVERSE EVENTS WERE ALLEGED. THE E602 ANALYZER SERIAL NUMBER USED AT THE CUSTOMER SITE WAS ASKED FOR, BUT NOT PROVIDED. THE COBAS 8000 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE TSH REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 180809, WITH AN EXPIRATION DATE OF 06/30/2015. THE E411 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER (B)(4). THE TSH REAGENT LOT NUMBER USED ON THIS ANALYZER WAS 183222, WITH AN EXPIRATION DATE OF 09/30/2015. INVESTIGATIONS OF THE PROVIDED DATA HAVE CONCLUDED THAT A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. UPON COMPARING VALUES GENERATED BY DIFFERENT TYPES OF ANALYZERS, VARIANCES CAN BE EXPECTED. FOR THYROID PARAMETERS, AGE, GENDER, AND OTHER CHARACTERISTICS ARE TO BE CONSIDERED WHEN ANALYZING MEASURED VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258733 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1