BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TSH ASSAY

    MDR report key: 6043240 · Received October 20, 2016

    Report

    Report Number
    1823260-2016-01594
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Date of Event
    September 21, 2016
    Report Date
    December 20, 2016
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED AS NO SAMPLE MATERIAL FROM THE PATIENT WAS AVAILABLE FOR FURTHER INVESTIGATION. FROM ANALYSIS OF THE CALIBRATION SIGNALS AND CONTROL VALUES, A GENERAL REAGENT ISSUE COULD MOST LIKELY BE EXCLUDED. THE DIFFERENCES IN THE RESULTS GENERATED WITH THE DIFFERENT ANALYZERS MAY BE CAUSED BY THE PRESENCE OF AN INTERFERING FACTOR THAT AFFECTS THE ASSAY FROM EITHER MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL RESULTS FOR THE PATIENT WERE PROVIDED. REFER TO THE ATTACHMENT TO THE MEDWATCH. REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE FT4 ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS TSH ASSAY RESULTS FOR ONE PATIENT SAMPLE FROM A COBAS E601 ANALYZER. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. NO UNITS OF MEASURE WERE PROVIDED. THE INITIAL RESULT WAS 15.49 AND WAS REPORTED OUTSIDE THE LABORATORY, BUT IT WAS NOT BELIEVED BY THE CLINICIAN AS IT DID NOT FIT WITH THE CLINICAL PICTURE. THE SAME SAMPLE WAS REPEATED ON (B)(6) 2016 AND THE RESULTS WERE 15.87 AND 15.67. THE LABORATORY SENT THE SAMPLE TO ANOTHER SITE FOR TESTING WHICH SHE BELIEVED USED AN ABBOTT ANALYZER. THE RESULT WAS 4.96 WHICH THEY BELIEVE TO BE THE CORRECT RESULT. THE PATIENT WAS NOT ADVERSELY AFFECTED OR TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695176 ELECSYS TSH ASSAY RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 159557

    Patients

    Seq Age Sex Outcome Treatment
    1