BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1083165 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05755
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 6, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LGD
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOUR SAMPLES WITH DISCREPANT TOXO IGG RESULTS. (REPEAT TESTING PERFORMED ON DIFFERENT ANALYZERS - DIFFERENT METHODOLOGIES). NO UNITS OF MEASURE PROVIDED FOR REPEAT RESULTS. SAMPLE 1, INITIAL RESULT GAVE 5.3 IU/ML; REPEATED TWICE GIVING 0.4 N AND 0.0 N. SAMPLE 2, INITIAL RESULT GAVE 29 IU/ML; REPEAT GAVE 2.4 G. SAMPLE 3, INITIAL RESULT GAVE 14 IU/ML; REPEATED TWICE GIVING 0.9 N AND 1 N. SAMPLE 4, INITIAL RESULT GAVE 38.7 IU/ML; REPEAT GAVE 1.6. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK