BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1221488 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08177
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED ONE PT WITH DISCREPANT HCG RESULTS. INITIAL RESULT GAVE 16.03 UIU/ML; REPEAT GAVE 15.80 UIU/ML. NEXT DAY SAMPLE WAS REPEATED TWICE RESULTING AT 17.06 AND 26.01 UIU/ML. ERRONEOUS RESULT WAS REPORTED AND CORRECTED REPORT POSTED. PT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK