BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1244868 · Received November 20, 2008

    Report

    Report Number
    1823260-2008-08610
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Date of Event
    November 10, 2008
    Report Date
    November 20, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    LTJ
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A QUESTIONABLE TOTAL PSA RESULT FOR ONE PT SAMPLE. THE SAMPLE INITIALLY RECOVERED 0.052 NG/ML. THIS RESULT WAS QUESTIONED BY A PHYSICIAN AND THE TEST WAS REPEATED GIVING 5.69 NG/ML. THE SAMPLE WAS ALSO REPEATED AT A 1.50 DILUTION AND GAVE 9.63 NG/ML. THE QUESTIONABLE RESULT WAS REPORTED AND THE PT WAS NOT TREATED BASED ON THIS RESULT. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE. 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 LTJ HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR