BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FT4, FREE THYROXINE

    MDR report key: 2121569 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03206
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEC
    PMA / PMN Number
    K961489
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY RECEIVED A QUESTIONABLE RESULT FOR FREE T4 ON THEIR COBAS E601 ANALYZER (SERIAL NUMBER (B)(4)). THE CUSTOMER PROVIDED DATA FOR ONE PATIENT WITH DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. THE REPEAT TESTING WAS PERFORMED ON THE SAME E601 ANALYZER. THE PATIENT'S INITIAL RESULT WAS 7.77 NG/DL ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 7.77 NG/DL ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 0.810 NG/DL WHICH WAS ISSUED AS A CORRECTED REPORT. THERE WERE NO ADVERSE AFFECTS TO THE CUSTOMER AS A RESULT OF THIS EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE MAY HAVE BEEN BAD PINCH TUBING OR THE PRO CELL NOT BEING PRIMED UP. HE REPLACED THE PINCH TUBING. HE RAN DIAGNOSTICS WITHIN SPECIFICATION. THE CUSTOMER PERFORMED CALIBRATION AND QUALITY CONTROL WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FT4, FREE THYROXINE RADIOIMMUNOASSAY, FREE THYROXINE CEC ROCHE DIAGNOSTICS NA 16033203

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR