BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1032579 · Received April 21, 2008

    Report

    Report Number
    1823260-2008-03437
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 4, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTS ONE PATIENT SAMPLE THAT GENERATED FREE T3 AND FREE T4 RESULTS WHICH DID NOT FIT WITH THE CLINICAL PICTURE OF THE PATIENT. INITIAL FREE T3 RESULT GAVE 32.55 PMOL/L, FREE T4 GAVE 12. PMOL/L, AND TSH GAVE 4.54 UIU/ML. A SECOND SAMPLE WAS OBTAINED FROM THE PATIENT, AND WAS TESTED USING TWO DIFFERENT METHODOLOGIES. NO DATE PROVIDED FOR THIS SECOND SAMPLE. FIRST METHOD GAVE FREE T3 OF 3.38, FREE T4 OF 0.9 NG/ML AND TSH OF 6.76 UIU/ML. SAMPLE REPEATED BY ANOTHER METHOD GAVE FREE T3 OF 1.88 PG/ML, FREE T4 OF 0.94 NG/DL AND TSH OF 4.57 UIU/ML. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. THE INVESTIGATION UNIT DID NOT VERIFY CUSTOMER COMPLAINT. PATIENT SAMPLE/S WAS NOT AVAILABLE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR