BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 1010

    MDR report key: 1060127 · Received June 11, 2008

    Report

    Report Number
    1823260-2008-04656
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 15, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT PTH RESULTS. INITIAL RESULT GAVE 35.79 MG/ML; REPEAT GAVE 104.9 PG/ML. ERRONEOUS RESULT REPORTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE DISCREPANCY WAS DUE TO A MISADJUSTED SAMPLE NEEDLE, AND ADJUSTED AND ALIGNED THE S/R NEEDLE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 1010 IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS 1010

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR