BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 2266679 · Received September 28, 2011

    Report

    Report Number
    1823260-2011-05130
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Date of Event
    August 21, 2011
    Report Date
    February 2, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION CONCERNING THE PATIENT WAS PROVIDED. THE MOTHER OF THE PATIENT WAS NORMAL (EUTHYROID). THE PATIENT WAS ONLY (B)(6) AND THE HYPOTHYROIDISM WAS DETECTED ON (B)(6) 2010 WITH A TSH RESULT OF 17.007 UUI/ML. THE PATIENT RECEIVED EUTIROX IN (B)(6) AND THE TSH RESULT WAS BACK TO NORMAL AT 2.401 UUI/ML BUT IN THE NEXT MONTH THE TSH RESULT WAS 45.805 UUI/ML. ON (B)(6) 2010, THE TSH RESULT WAS 49.044 UUI/ML AND THE DOCTOR INCREASED THE MEDICINE DOSE. ON (B)(6) 2010, THE RESULT FOR TSH WAS 29.020 UUI/ML ON (B)(6) 2011, THE TSH RESULT WAS 0.010 UUI/ML ON (B)(6) 2011, THE TSH RESULT WAS 0.015 UUI/ML AND THE MEDICINE DOSE WAS DECREASED. ON (B)(6) 2011, THE TSH RESULT WAS 0.960 UUI/ML ON (B)(6) 2011, THE TSH WAS MEASURED IN TWO DIFFERENT LABS ONE USING ECL AND THE RESULT WAS >48.00 UUI/ML AND IN ANOTHER LAB USING CLIA THE RESULT WAS <0.20 UUI/ML.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS NO SAMPLE FROM THE PATIENT COULD BE PROVIDED FOR FURTHER TESTING.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE THYROTROPIN (TSH) RESULTS FOR ONE PATIENT SAMPLE WHEN COMPARED TO THE CENTAUR ANALYZER. THE RESULTS FROM THE ANALYTICAL E MODULE ANALYZER WERE: ON (B)(6) 2011, THE RESULT WAS 40.221 UUI/ML. ON (B)(6) 2011, THE RESULT WAS 42.271 UUI/ML FROM A DIFFERENT ANALYTICAL E MODULE ANALYZER. THE RESULTS FROM THE CENTAUR ANALYZER WERE: ON (B)(6) 2011, THE RESULT WAS 1.077 UUI/ML. ON (B)(6) 2011, THE RESULT WAS 0.923 UUI/ML. FROM A NEW SAMPLE ON (B)(6) 2011, THE RESULT FROM THE CENTAUR ANALYZER WAS 1.006 UUI/ML AND WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS NOT ADVERSELY AFFECTED AND WAS UNDER TREATMENT. THE TSH REAGENT LOT NUMBER WAS 161438. THE FIELD APPLICATION SPECIALIST VERIFIED THE CALIBRATION AND QUALITY CONTROLS RESULTS WERE IN THE ACCEPTABLE RANGE. PERFORMANCE TESTING WAS ALSO RUN WITH THE RESULTS ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 002 YR EUTIROX