BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 2221368 · Received August 24, 2011

    Report

    Report Number
    1823260-2011-04530
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 8, 2011
    Report Date
    November 18, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION DETERMINED THE MOST PROBABLE CAUSE OF THE ERRONEOUS RESULTS WAS LIQUID IN THE ELECTRODE CHAMBER. THE FIELD SERVICE REPRESENTATIVE VISITED THE SITE A SECOND TIME. HE FOUND MOISTURE UNDER THE ELECTRODES AND FOUND AN ELECTRODE LOCKING SPRING WAS LOOSE, THEREFORE NOT HOLDING THE ELECTRODES SECURE. HE CLEANED AND REPAIRED THE ELECTRODE CHAMBER AND THE LOCKING SPRING WHICH SOLVED THE ISSUE. NO PATIENTS WERE ADVERSELY AFFECTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS INTERMITTENTLY SINCE THE END OF (B)(6) ON THEIR MODULAR ANALYTICS CORE. THE CUSTOMER PROVIDED DATA FOR 20 PATIENTS, OF WHICH THERE WERE TWO DISCREPANT RESULTS REPORTED OUTSIDE THE LABORATORY. A DOCTOR QUESTIONED A HIGH SODIUM RESULT. THE REPEAT TESTING WAS PERFORMED ON THE SAME MODULE ON (B)(6) 2011. THE FIRST PATIENT HAD AN INITIAL SODIUM RESULT OF 132 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. THE SECOND PATIENT HAD AN INITIAL SODIUM RESULT OF 134 MMOL/L. THE REPEAT RESULT WAS 142 MMOL/L. THE CUSTOMER DEEMED THE REPEAT RESULTS WERE CORRECT. THE SODIUM ELECTRODE LOT NUMBER WAS I17 AND THE EXPIRATION DATA WAS (B)(6) 2011. THE CUSTOMER WAS UNABLE TO PROVIDE ANY DATA ON THE PATIENTS' CONDITION. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE EVENT WAS CAUSED BY A FAILED IS VALVE, A CRACKED IS SYRINGE SPRING, AND HE SUSPECTED THE DILUENT VALVE WAS FAILING. HE REPLACED THE IS VALVE, THE DILUENT VALVE, AND THE IS SYRINGE SPRING. THE CUSTOMER PERFORMED QUALITY CONTROL WITH RESULTS WITHIN RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1