BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADDITIONAL D MODULE

    MDR report key: 1761062 · Received July 19, 2007

    Report

    Report Number
    1823260-2007-06280
    Event Type
    Malfunction
    Date Received
    July 19, 2007
    Date of Event
    June 28, 2007
    Report Date
    July 19, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATED THEY WERE GETTING HIGH CO2 RESULTS THAT WERE LOWER WHEN REPEATED. THEY GAVE THE FOLLOWING FOUR EXAMPLES (INITIAL/REPEAT MMOL/L): #1- 39/25, #2- 41/29, #3- 45/27 #4- 41/27, #5- 42/21. THE INCORRECT RESULTS DID NOT CAUSE AN ADVERSE EVENT. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE FOR THE DISCREPANCIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA