BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4642756 · Received March 30, 2015

    Report

    Report Number
    1823260-2015-02561
    Event Type
    Malfunction
    Date Received
    March 30, 2015
    Date of Event
    March 10, 2015
    Report Date
    April 7, 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

    DURING INVESTIGATIONS, THE FT3, FT4 AND TSH VALUES GENERATED AT CUSTOMER SITE WERE REPRODUCED. A FURTHER CLARIFICATION OF THE OBSERVED DISCREPANCIES, WITH RESPECT TO THE NORMAL REFERENCE RANGES OF THE ROCHE AND SIEMENS ASSAYS, IS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART. IT IS HOWEVER KNOWN THAT DIFFERENT ASSAYS CAN GENERATE DIFFERENT VALUES. THIS IS RELATED TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND THE STANDARDIZATION METHODOLOGY USED. IN ADDITION, THE VALUES OF THYROID PARAMETERS VARY IN FUNCTION OF AGE, GENDER AND OTHER POPULATION CHARACTERISTICS.

    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 FOUR PATIENT SAMPLES TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). OF THE FOUR SAMPLES, ONE HAD ERRONEOUS RESULTS FOR TSH AND FT3. IT WAS ASKED, BUT THE DATE OF THE EVENT IS NOT KNOWN. THIS MEDWATCH WILL COVER TSH. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION REFERRING TO 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 AN E170 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. 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 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 SEPTEMBER 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 SEPTEMBER 2015. THE PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION AND INVESTIGATIONS HAVE DETERMINED THAT NO INTERFERING FACTOR COULD BE IDENTIFIED IN THE SAMPLE. THE TSH VALUE WAS FOUND TO BE WITHIN THE REFERENCE RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208310 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1