BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2010 RACK ELECSYS

    MDR report key: 1761283 · Received July 20, 2007

    Report

    Report Number
    1823260-2007-06339
    Event Type
    Malfunction
    Date Received
    July 20, 2007
    Date of Event
    June 15, 2007
    Report Date
    July 20, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    INITIAL PTH RESULT 81.9 PMOL/L. SAME SAMPLE REPEATED USING DIFFERENT METHODOLOGY GAVE RESULT OF 8.1 PMOL/L. THE INITIAL RESULT WAS REPORTED. NO INFORMATION PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR COUMADIN - 8 MGS VARIES| KAYEXALATE - 15 GM| PHOSLO - 667 MG 3 WITH EACH| RENAL CAPS - 1/DAY| POTASSIUM IODIDE - 10 MEQ PO QD| LIPITOR - 20 MG PO QD| AMBIEN - 10 MGS PO QHS| PREVACID - 20 MGS PO QD| POTASSIUM SALTS - 40 MEQ PO BID| BIOTIN FORTE - 5,000 MGS/DAY| EFFEXOR XR - 112.5 PO QD