BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1162207 · Received September 16, 2008

    Report

    Report Number
    1823260-2008-06923
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 21, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS OF HCG AND CORTISOL. TWO PATIENT SAMPLES WERE INVOLVED. SAMPLE 1 INITIAL HCG RESULT 5 MIU/ML. INITIAL RESULT WAS REPORTED AND WAS QUESTIONED BY THE DOCTOR WHO HAD PATIENT REDRAWN. REDRAW SAMPLE GAVE INITIAL RESULT OF > 10000 MIU/ML AND REPEAT GAVE 72720 MIU/ML. RESULT FROM REDRAW WAS THEN REPORTED. PATIENT WAS NOT ADVERSELY AFFECTED. ORIGINAL SAMPLE WAS THEN REPEATED IN 2008 WHICH RESULTED 81236 MIU/ML. ON TWO DAYS LATER, SAMPLE 2 INITIAL CORTISOL RESULT <1 UG/DL, REPEAT GAVE 14 UG/ML TWICE. REPEAT RESULT WAS REPORTED. NO ADVERSE EVENTS REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS NOT ABLE TO DETERMINE A CAUSE, BUT NOTED HE CHECKED THE ANALYZER AND REPLACED THE MEASURING CELL. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK