BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1901455 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06795
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    September 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DCN
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER FAILED OUT LOW ON ONE EXTERNAL PROFICIENCY SURVEY SAMPLE FOR C-REACTIVE PROTEIN GENERATION 3 (CRPL3) ON THE COBAS 6000 C501 ANALYZER. THE REPORTED SURVEY RESULT WAS 4.41 MG/DL. THE EXPECTED MEAN WAS 5.84 MG/DL. THE SURVEY SAMPLE WAS REPEATED ON (B)(6) 2010 WHICH YIELDED A RESULT OF 4.59 MG/DL. NO PATIENT SAMPLES WERE AFFECTED BY THIS EVENT. THE REAGENT LOT NUMBER FOR CRPL3 WAS 62161401. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE WAS FLUIDICS FAILURE OF THE SAMPLE PROBE. HE REPLACED THE SAMPLE PROBE AND PERFORMED ADJUSTMENTS. HE ALSO REPLACED THE SAMPLE AND REAGENT PROBE SYRINGE SEALS AND PERFORMED CLEANING MAINTENANCE. PERFORMANCE TESTS WERE RUN AND WERE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER DCN ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1