BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1874327 · Received October 19, 2010

    Report

    Report Number
    1823260-2010-06209
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LEH
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR VANCOMYCIN ON THE INTEGRA 400 PLUS ANALYZER. THE EVENT INVOLVED TWO PATIENT SAMPLES WHICH GAVE DISCREPANT RESULTS. PATIENT SAMPLE 1, THE INITIAL VANCOMYCIN TROUGH RESULT GAVE 54.0 UG/ML. THE SAMPLE WAS REPEATED THREE TIMES GIVING 9.8, 9.3 & 9.8 UG/ML. THE VANCOMYCIN TROUGH RESULT OF 9.8 UG/ML WAS REPORTED OUTSIDE THE LABORATORY. PATIENT SAMPLE 2, MALE (B)(6), DATE OF BIRTH (B)(6). THE INITIAL VANCOMYCIN RANDOM RESULT GAVE 46.9 UG/ML. THE SAMPLE WAS REPEATED THREE TIMES GIVING 21.4, 22.0 & 21.8 UG/ML. THE REPEAT RANDOM VANCOMYCIN RESULT OF 21.4 UG/ML WAS REPORTED OUTSIDE THE LABORATORY. THE USER SAID THE ORIGINAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENTS WERE NOT AFFECTED. THE VANCOMYCIN REAGENT LOT NUMBER WAS 62066601. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS FLUIDICS FAILURE OF THE PROBE. HE REPLACED THE PROBE. PERFORMANCE TESTS WERE RUN AND WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER LEH ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR