BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4657017 · Received April 3, 2015

    Report

    Report Number
    1823260-2015-02709
    Event Type
    Malfunction
    Date Received
    April 3, 2015
    Date of Event
    March 19, 2015
    Report Date
    May 4, 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

    THE AFFECTED PATIENT SAMPLE WAS PROVIDED FOR INVESTIGATION. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED FOR THE ERRONEOUS TSH RESULTS. A FURTHER CLARIFICATION OF THE DISCREPANCY IS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). 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 FT4. 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. THE RESULT VALUES OBTAINED DURING 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 E170 ANALYZER USED FOR INVESTIGATION PURPOSES WAS SERIAL NUMBER 1519-01. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222557 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1