BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1902096 · Received November 18, 2010

    Report

    Report Number
    1823260-2010-06806
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 4, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MOST LIKELY THE DEFECTIVE VALVES ON THE DILUENT SYRINGES CAUSED THE HIGH RESULT ALTHOUGH A PIPETTING ERROR AND/OR INCORRECT ADJUSTMENT OF NOZZLES COULD NOT BE EXCLUDED. THE REPLACED VALVES WERE NOT AVAILABLE FOR INVESTIGATION. FURTHER INVESTIGATION WAS NOT POSSIBLE AS THE CUSTOMER WAS NOT WILLING TO COOPERATE OR PROVIDE FURTHER DATA.

    Description of Event or Problem · 1

    THE USER INTERMITTENTLY RECEIVED QUESTIONABLE ISE RESULTS AND PROVIDED DATA FOR ONE PATIENT SAMPLE. OF THE DATA PROVIDED, THE SODIUM RESULT WAS DISCREPANT. THE INITIAL RESULT WAS 151 MMOL/L AND THE REPEAT RESULT WAS 143 MMOL/L. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENT WAS NOT AFFECTED. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND REPLACED THE VALVES ON THE DILUENT SYRINGES. TO VERIFY THE ANALYZER OPERATION, HE RAN A PRECISION STUDY AND ISE CHECKS. THE USER RAN CALIBRATION AND QUALITY CONTROL WITH ALL RESULTS WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1