BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TSH, THYROTROPIN

    MDR report key: 2082249 · Received May 9, 2011

    Report

    Report Number
    1823260-2011-02464
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 11, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961491
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLE WAS NOT PROVIDED FOR INVESTIGATION AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REAGENT RELATED ISSUE SEEMS VERY UNLIKELY. THIS IS SUPPORTED BY THE FACT THAT THE ELECSYS TSH VALUES WERE VERIFIED BY A COMPETITOR SYSTEM AND THE CALIBRATION DATA PROVIDED WAS WITHIN THE EXPECTED RANGE. NO ADVERSE EVENTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE THYROID STIMULATING HORMONE (TSH) RESULTS FOR ONE PATIENT SAMPLE WHEN TESTED ON A COBAS 6000 E601 MODULE (SERIAL NUMBER NOT PROVIDED). THE INITIAL TSH RESULT WAS 3.86 MIU/ML. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO INTERVENTION OR DRUGS GIVEN TO THE PATIENT. THE SAMPLE WAS SENT TO AN OUTSIDE LABORATORY AND REPEATED ON AN ABBOTT ARCHITECT WHERE IT RECOVERED 2.92 MIU/ML. THE RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT HARMED. THE PATIENT IS STABLE AND WAS SHIFTED TO THE PAY WARD OF THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSH, THYROTROPIN RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE JLW ROCHE DIAGNOSTICS NA 160029

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR LASICALTO| LASIX| ATORVASTATIN| CALCATIN| ALTATONE| WARFARIN