BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 4646826 · Received March 31, 2015

    Report

    Report Number
    1823260-2015-02594
    Event Type
    Malfunction
    Date Received
    March 31, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 31, 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 FOUR PATIENT SAMPLES TESTED FOR THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), AND FREE THYROXINE (FT4). OF THE FOUR SAMPLES, ONE HAD ERRONEOUS RESULTS FOR TSH. THE SPECIFIC DATE OF THE EVENT WAS REQUESTED BUT NOT PROVIDED. 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 INVESTIGATION DATA AND CENTAUR DATA WERE REPORTED 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 (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. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL SAMPLE FROM THE PATIENT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION. BASED UPON THE INFORMATION PROVIDED, A GENERAL REAGENT ISSUE IS MOST LIKELY NOT PRESENT. WHEN COMPARING VALUES GENERATED BY DIFFERENT TYPES OF ANALYZERS, VARIANCES CAN BE EXPECTED. GIVEN THE DIFFERENT SETUPS OF ALL ASSAYS, THE ANTIBODIES USED, AND THE VARIANCES IN REFERENCE METHODS, DIFFERENCES IN VALUES MAY OCCUR WHEN COMPARING THESE ASSAYS FROM DIFFERENT VENDORS. 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
    212300 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1