BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THYROTROPIN

    MDR report key: 2102298 · Received May 25, 2011

    Report

    Report Number
    1823260-2011-02798
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY RECEIVED A QUESTIONABLY LOW THYROTROPIN (TSH) RESULT ON THEIR COBAS E411 RACK SYSTEM (SERIAL NUMBER (B)(4)). THE TECHNOLOGIST QUESTIONED THE LOW RESULT AND DECIDED TO REPEAT THE TEST. THE REPEAT TESTING WAS PERFORMED ON THE SAME E411 ANALYZER. THE PATIENT'S INITIAL TSH RESULT WAS 0.034 UIU/ML ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 4.29 UIU/ML. THE SECOND REPEAT RESULT WAS 4.32 UIU/ML. THE ORIGINAL ERRONEOUS RESULT WAS NEVER REPORTED OUTSIDE THE LABORATORY SO THE PATIENT WAS NOT ADVERSELY AFFECTED AND THERE WAS NO RESULTING TREATMENT. THE CUSTOMER REFUSED A FIELD SERVICE VISIT. UPON FURTHER INVESTIGATION, NO ROOT CAUSE COULD BE DETERMINED. CALIBRATION AND QUALITY CONTROL BOTH PASSED PRIOR TO THE ANALYSIS INDICATING THE CAUSE WAS LIKELY NOT A REAGENT MALFUNCTION. THE CUSTOMER REPORTED SEEING A DROP OF LIQUID ON THE INNER WALL OF THE SAMPLE TUBE. THE DROP OF LIQUID COULD BE A POSSIBLE REASON FOR PREMATURE LIQUID LEVEL DETECTION LEADING TO AN INITIAL FALSE LOW RESULT. THERE WERE NO DETAILED PATIENT DATA PROVIDED IN THIS CASE. IT WAS UNKNOWN WHY DETERMINATION OF TSH WAS PERFORMED. THE LOW RESULT WAS NOT REPORTED OUTSIDE OF THE LAB. THE CUSTOMER CONFIRMED THAT THE PATIENT WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 16107903

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR