BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISE INDIRECT K+ FOR GEN.2

    MDR report key: 2141570 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03471
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ION SELECTIVE ELECTRODE (ISE) POTASSIUM RESULTS FOR FIVE PATIENT SAMPLES FROM THE MODULAR ANALYTIC CORE ANALYZER SERIAL NUMBER (B)(4). OF THE DATA PROVIDED, THE RESULTS FOR THREE OF THE SAMPLES WERE DISCREPANT. THE ISSUE WAS DISCOVERED WHEN THE ER ALERTED THE LABORATORY OF LOW SODIUM RESULTS. ALL RESULTS ARE IN MMOL/L. PATIENT SAMPLE 1 INITIAL RESULT WAS 4.1 AND THE REPEAT RESULT WAS 4.6. PATIENT SAMPLE 2 INITIAL RESULT WAS 3.5 AND THE REPEAT RESULT WAS 4.0. PATIENT SAMPLE 3 INITIAL RESULT WAS 3.9 AND THE REPEAT RESULT WAS 4.4. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE ISSUED. NO PATIENTS WERE ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE ISE DILUENT AND STANDARD VOLUME WERE LOW. HE REPLACED THE ISE DILUENT AND STANDARD BOTTLES. TO VERIFY THE ANALYZER OPERATION, HE RAN CALIBRATION AND QUALITY CONTROL WITH RESULT WITHIN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISE INDIRECT K+ FOR GEN.2 ELECTRODE, ION SPECIFIC, POTASSIUM CEM ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1