BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1052718 · Received May 23, 2008

    Report

    Report Number
    1823260-2008-04294
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PTS WITH LOW ISE RESULTS. INITIAL RESULTS NOT REPORTED, PTS NOT ADVERSELY AFFECTED. REPEAT RESULTS OCCURRED ON DIFFERENT ANALYZER (ALTERNATE METHODOLOGY). PT 1: INITIAL SODIUM RESULT 23 MMOL/L, REPEAT 127 MMOL/L. PT 2: INITIAL SODIUM RESULT 62 MMOL/L, REPEAT 143 MMOL/L. INITIAL POTASSIUM RESULT 2 MMOL/L, REPEAT 4.9 MMOL/L. FIELD SERVICE REP UNABLE TO REPRODUCE PROBLEM BUT FOUND BENT ISE SAMPLE PROBE WHICH WAS REPLACED. PERFORMANCE TESTS WERE PERFORMED AND WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK