BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 2033073 · Received March 30, 2011

    Report

    Report Number
    1823260-2011-01687
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) SODIUM RESULTS THAT WERE DISCOVERED WHEN THE SAMPLES WERE RETESTED AFTER INTERMITTENT QUALITY CONTROL ISSUES THAT WERE RESOLVED WITH RECALIBRATION. THE USER PROVIDED DATA FOR FOUR PATIENT SAMPLES, OF WHICH TWO WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WITH AN ALIQUOT WAS 146 MMOL/L AND THE REPEAT RESULT WITH THE SAME ALIQUOT WAS 139 MMOL/L. THE PRIMARY SAMPLE TUBE WAS REPEATED ON ANOTHER ANALYZER WITH A RESULT OF 143 MMOL/L. PATIENT SAMPLE 2 INITIAL RESULT WITH AN ALIQUOT WAS 146 MMOL/L AND THE REPEAT RESULT WITH THE SAME ALIQUOT WAS 140 MMOL/L. THE PRIMARY SAMPLE TUBE WAS REPEATED ON ANOTHER ANALYZER WITH A RESULT OF 143 MMOL/L. IT WAS UNKNOWN IF THE PATIENTS WERE ADVERSELY AFFECTED. THE SODIUM ELECTRODE LOT NUMBER WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE REAGENT SYSTEM AND THE DILUENT/INTERNAL STANDARD NOZZLE WAS MISADJUSTED. HE ADJUSTED THE NOZZLE AND VERIFIED THE ANALYZER OPERATION BY RUNNING CALIBRATION, QUALITY CONTROL AND PRECISION TESTING WITH RESULTS WITHIN SPECIFICATION.

    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