BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1935297 · Received December 22, 2010

    Report

    Report Number
    1823260-2010-07621
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 9, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR ION-SELECTIVE ELECTRODE (ISE) POTASSIUM ON BOTH ISE MODULES (ISE-1) AND (ISE-2) ON THE SAME MODULAR CORE ANALYZER. THE EVENT INVOLVED 3 PATIENT SAMPLES. TWO SAMPLES WERE DISCREPANT. THE USER COULD NOT PROVIDE WHICH ISE MODULE (ISE-1) OR (ISE-2) THE ORIGINAL OR REPEAT POTASSIUM RESULTS WERE GENERATED FROM FOR THESE PATIENT SAMPLES. PATIENT SAMPLE 1, THE ORIGINAL RESULT WAS 4.8 MMOL/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED WHICH YIELDED A RESULT OF 4.2 MMOL/L. THIS REPEAT POTASSIUM RESULT WAS SENT AS THE CORRECTED RESULT FOR THIS PATIENT SAMPLE. PATIENT SAMPLE 2, THE INITIAL RESULT WAS 5.0 MMOL/L. THIS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED WHICH YIELDED A RESULT OF 4.0 MMOL/L. THIS REPEAT POTASSIUM RESULT WAS SENT AS THE CORRECTED RESULT FOR THIS PATIENT SAMPLE. NO ADVERSE EVENTS HAVE BEEN ALLEGED REGARDING THESE DISCREPANCIES. THE ELECTRODE LOT NUMBER FOR POTASSIUM WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS CONTAMINATED SAMPLE PROBE. HE REPLACED THE PROBE AND PERFORMED PROBE ADJUSTMENTS. PERFORMANCE TESTS WERE RUN WHICH WERE SUCCESSFUL.

    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