BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1060124 · Received June 11, 2008

    Report

    Report Number
    1823260-2008-04653
    Event Type
    Malfunction
    Date Received
    June 11, 2008
    Date of Event
    May 18, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH DISCREPANT RESULTS FOR MULTIPLE ASSAYS. PATIENT 1, INITIAL ALBUMIN RESULT 3.9 G/DL, REPEAT 2.6 G/DL; INITIAL CALCIUM RESULT 6.8 MMOL/L, REPEAT 8.1 MMOL/L; INITIAL BICARBONATE RESULT 41 MG/DL, REPEAT 22 MG/DL. PATIENT 2, INITIAL BICARBONATE RESULT 20 MG/DL, REPEAT 34 MG/DL. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE INCORRECT RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED A DEFECTIVE VALVE ON REAGENT #1 PIPETTOR WAS THE CAUSE AND REPLACED THE VALVE. HE ALSO NOTED HE REPLACED DEFECTIVE HIGH CONCENTRATION WASTE LINES ON NOZZLES 2 & 6. PERFORMANCE TESTS PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK