BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1001786 · Received February 19, 2008

    Report

    Report Number
    1823260-2008-01695
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 22, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS RECEIVING DISCREPANT RESULTS. ISSUE POTENTIALLY BEGAN A FEW WEEKS AGO, HOWEVER, NO SPECIFIC INFORMATION COULD BE PROVIDED. USER PROVIDED 2 EXAMPLES OF DISCREPANT RESULTS WHICH OCCURRED IN 2008, REPEAT TESTING PERFORMED THE NEXT DAY. SAMPLE 1, INITIAL TSH RESULT <0.1, REPEAT RESULT 0.7, UNITS OF MEASURE NOT PROVIDED. ERRONEOUS RESULT WAS NOT REPORTED. SAMPLE 2, INITIAL HCG RESULT 20889, DILUTED AND REPEATED TWICE, GAVE RESULTS OF 47770 AND 47229, UNITS OF MEASURE NOT PROVIDED. INITIAL RESULT WAS REPORTED. NO ADVERSE EVENTS WERE REPORTED IN ASSOCIATION WITH THE ERRONEOUS RESULT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH S/R PROBE TUBING AND REPLACED THE TUBING. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK