BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1102020 · Received August 7, 2008

    Report

    Report Number
    1823260-2008-06021
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT BICARBONATE RESULTS. INITIAL RESULT, 1.0 MMOL/L, REPEAT 25.2 MMOL/L. ERRONEOUS RESULT WAS REPORTED. PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A PROBLEM WITH THE SAMPLE MECHANISM AND REPLACED THE SAMPLE MECHANISM ASSEMBLY AND CIRCUIT BOARD ASSEMBLY. 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