BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1001796 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01672
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 18, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT EXPERIENCING GETTING DISCREPANT RESULTS FOR MULTIPLE PATIENT SAMPLES FOR FREE T4 AND FOLATE. THE FOLLOWING EXAMPLES WERE PROVIDED. REPEAT TESTING OCCURRED IN 2008. FREE T4: SAMPLE 1, INITIAL GAVE 2.96 NG/DL; REPEAT GAVE 1.19 NG/DL. SAMPLE 2 INITIAL GAVE 2.54 NG/DL; REPEAT GAVE 0.977 NG/DL. SAMPLE 3, INITIAL GAVE 5.57 NG/DL; REPEAT GAVE 1.11 NG/DL. SAMPLE 4, INITIAL GAVE 2.67 NG/DL; REPEAT GAVE 1.03 NG/DL. SAMPLE 5, INITIAL GAVE 2.91 NG/DL; REPEAT GAVE 1.16. SAMPLE 6, INITIAL GAVE 2.50 NG/DL; REPEAT GAVE 0.926 NG/DL. SAMPLE 7, INITIAL GAVE 2.47 NG/DL; REPEAT GAVE 1.00 NG/DL. SAMPLE 8, INITIAL GAVE 3.10 NG/DL; REPEAT GAVE 1.34 NG/DL. SAMPLE 9, INITIAL GAVE 2.22 NG/DL; REPEAT GAVE 1.00 NG/DL. SAMPLE 10, INITIAL GAVE 3.08 NG/DL; REPEAT GAVE 1.37 NG/DL. SAMPLE 11, INITIAL GAVE 2.71 NG/DL; REPEAT GAVE 1.15 NG/DL. SAMPLE 12, INITIAL GAVE 2.13 NG/DL; REPEAT GAVE 0.961 NG/DL. SAMPLE 13, INITIAL GAVE 2.96 NG/DL; REPEAT GAVE 1.30 NG/DL. SAMPLE 14, INITIAL GAVE 2.44 NG/DL; REPEAT GAVE 1.11 NG/DL. SAMPLE 15, INITIAL GAVE 2.08 NG/DL; REPEAT GAVE 0.823 NG/DL. SAMPLE 16, INITIAL GAVE 2.52 NG/DL; REPEAT GAVE 1.14 NG/DL. FOLATE: SAMPLE 1, INITIAL GAVE >20 NG/ML; REPEAT GAVE 11.70 NG/ML. SAMPLE 2, INITIAL GAVE >20 NG/ML; REPEAT GAVE 11.30 NG/ML. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK