BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1871335 · Received October 15, 2010

    Report

    Report Number
    1823260-2010-06160
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 10, 2010
    Report Date
    June 24, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JLW
    PMA / PMN Number
    K961481
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS EVENT OCCURRED IN THE (B)(6).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONCERNING THE ISSUE. THE TSH REAGENT LOT NUMBER WAS 158999. THE FT4 REAGENT LOT NUMBER WAS 158155. THE FT3 REAGENT LOT NUMBER WAS 156811. WHEN THE PATIENT WAS DIAGNOSED AS THYROTOXIC IN (B)(6) 2007, BUT HAD NO SYMPTOMS, THE TSH RESULT WAS 0.05 MIU/L. THE PATIENT HAD SEVERAL COURSES OF CARBIMAZOLE OVER THE PAST 3 YEARS AS A CONSEQUENCE OF MISDIAGNOSIS AND "HAD 3 YEARS OF MISERY HAVING BEEN RENDERED CLINICALLY AND BIOCHEMICALLY HYPOTHYROID BY TREATMENT FOR A CONDITION HE DOES NOT HAVE."

    Additional Manufacturer Narrative · 1

    A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. A HIGH CONCENTRATION OF IGM, SIGNIFICANTLY ABOVE THE NORMAL RANGE, WAS DETECTED IN THE PATIENT SAMPLE. THE FALSE RESULTS WERE MOT LIKELY CAUSED BY THE HIGH IGM CONCENTRATION PRESENT IN THIS SAMPLE.

    Additional Manufacturer Narrative · 1

    A NEW SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. INTEFERENCE TESTING WAS PERFORMED ON THE PATIENT SAMPLE. RUTHENIUM INTEFERENCE WEAS EXCLUDED. PRESENCE OF AN INTERFERING FACTOR IN THE PATIENT SAMPLE IS SUSPECTED, HOWEVER DUE TO THE INSUFFICIENT SAMPLE VOLUME,FURTHER INVESTIGATION WAS NOT POSSIBLE. THE ROOT CAUSE REMAINS UNCLEAR. THE PATIENT'S CURRENT CONDITION IS "IMPROVED SINCE STOPPING DRUG TREATMENT".

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE THYROID RESULTS FOR SEVERAL SAMPLES FROM ONE PATIENT TESTED ON THE ANALYTICAL E MODULE (E170). DATA WAS PROVIDED FOR ONE SAMPLE TESTED ON (B)(6)2010. A SAMPLE GAVE A TSH (THYROID-STIMULATING HORMONE, THYROTROPIN) RESULT OF 0.29 MIU/L, A FT4 (FREE THYROXINE) RESULT OF 31.1 PMOL/L AND A FT3 (FREE TRIIODOTHYRONINE) RESULT OF 16.75 PMOL/L. BASED ON THESE RESULTS, THE PATIENT WAS TREATED WITH CARBIMAZOLE. HE FELT UNWELL SO THE MEDICATION WAS STOPPED AND THE SAMPLE WAS SENT TO A DIFFERENT LABORATORY THAT USED ABBOTT METHODOLOGY. THE RESULTS WERE A TSH OF 2.70 MIU/L, A FT4 OF 14.0 PMOL/L AND A FT3 OF 5.0 PMOL/L. IT WAS NOTED THE PATIENT'S GENERAL HEALTH DETERIORATED AS A CONSEQUENCE OF THE CARBIMAZOLE. THE PATIENT FELT UNWELL AND WAS LETHARGIC. THE TSH, FT4 AND FT3 REAGENT LOT NUMBERS WERE NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE AN UNKNOWN PROCEDURE, WHEN THE PACKAGE WAS OPENED, THE JAW WAS BROKEN. THE DEVICE WAS NOT USED FOR THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JLW ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR Other