BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADDITIONAL P MODULE

    MDR report key: 1760904 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-06021
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 12, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JFY
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2007, INITIAL CREATININE RESULT 240.5 UMOL/L. SAME SAMPLE REPEATED 4 DAYS LATER GAVE RESULT OF 97.5 UMOL/L. A NEW SAMPLE WAS TAKEN (B)(6) 2007 AND GAVE RESULT OF 86 UMOL/L. THE INITIAL SAMPLE WAS ALSO RETESTED ON (B)(6) 2007 USING DIFFERENT INSTRUMENT, USING 2 DIFFERENT METHODS AND GAVE RESULTS OF 94.7 UMOL/L AND 112 UMOL/L. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADDITIONAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JFY ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA IBUPROFEN| ENALAPID - 2X2.5 MG| HYDROCLOROTYRAZIET - 12.5 MG