BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4838750 · Received June 11, 2015

    Report

    Report Number
    1823260-2015-03605
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 20, 2015
    Report Date
    July 1, 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).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED BASED ON THE PROVIDED INFORMATION. FURTHER INVESTIGATIONS OF THE SAMPLE WERE NOT POSSIBLE AS THERE WAS NO REMAINING VOLUME OF THE SAMPLE LEFT FOR TESTING. GIVEN THE DIFFERENT SETUPS OF ALL ASSAYS, THE ANTIBODIES USED AND THE VARIANCES IN REFERENCE METHODS, DIFFERENCES IN VALUES MAY OCCUR WHEN COMPARING ASSAYS FROM DIFFERENT VENDORS. IN ADDITION, IT NEEDS TO BE TAKEN INTO ACCOUNT THAT THE VALUES OF ALL THYROID PARAMETERS VARY IN FUNCTION OF AGE, GENDER, AND OTHER POPULATION CHARACTERISTICS. THE DIFFERENCE IN VALUES FOR THE FT3 AND TSH PARAMETERS, FOR THE RUNS AT CUSTOMER SITE AND DURING THE INVESTIGATION WITH ROCHE ANALYZERS, MAY HAVE BEEN CAUSED BY VARIANCES IN THE CALIBRATION RUNS THAT SUPPORTED THE GENERATION OF THESE VALUES. THE POSITIONING OF ALL THE FT3 AND TSH VALUES, VERSUS THE NORMAL REFERENCE RANGES OF THE ASSAYS, IS THE SAME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). OF THE THREE TESTS, THE SAMPLE WAS FOUND TO HAVE ERRONEOUS RESULTS FOR FT3 AND TSH. IT WAS ASKED, BUT THE DATE OF THE EVENT IS NOT KNOWN. THIS MEDWATCH WILL COVER TSH. REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION REFERRING TO FT3. THE SAMPLE WAS INITIALLY TESTED AT THE CUSTOMER SITE ON AN UNKNOWN ROCHE ANALYZER. DURING INVESTIGATIONS, THE PATIENT SAMPLE WAS TESTED ON AN E170 ANALYZER AND A CENTAUR ANALYZER ON (B)(6) 2015. REFER TO THE ATTACHMENT FOR THE SPECIFIC PATIENT RESULT VALUES. IT WAS ASKED, BUT IT IS NOT KNOWN WHICH PATIENT RESULTS, IF ANY, WERE REPORTED OUTSIDE OF THE LABORATORY. THE INVESTIGATION RESULTS 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 ANALYZER MODEL AND SERIAL NUMBER USED AT THE CUSTOMER SITE WERE ASKED FOR, BUT NOT PROVIDED. THE E170 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381654 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1