BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1193363 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07390
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 16, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER HAVING ISSUES WITH QC FOR MULTIPLE ASSAYS AND PRECISION ISSUES FOR CREATININE AND CHOLESTEROL. ONE PATIENT SAMPLE INVOLVED. INITIAL CREATININE RESULT OF 0.2 MG/DL WAS RELEASED TO THE PHYSICIAN, WAS QUESTIONED AND RERAN. REPEAT RECOVERED 1.2 MG/DL. USER STATES HE DOES NOT BELIEVE THE PATIENT WAS TREATED BASED ON THE INITIAL RESULT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE R1 DISPENSE AND CORRECTED A FLUIDIC ISSUE WITH THE R1 REAGENT LINE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK