BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1911684 · Received December 1, 2010

    Report

    Report Number
    1823260-2010-07067
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEK
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE FIELD APPLICATION SPECIALIST REPORTED THE USER FAILED A PROFICIENCY SURVEY FOR TOTAL PROTEIN URINE/CSF GENERATION 3 (TOTAL PROTEIN) FOR TWO OF THREE URINE SAMPLES. OF THE DATA PROVIDED, THE RESULTS FOR ONE SAMPLE WERE DISCREPANT. THE ORIGINAL RESULT WAS 97.2 MG/DL. THE REPEAT RESULT ON COBAS C501 SERIAL NUMBER (B)(4) WAS 50.8 MG/DL. ON (B)(6) 2010, THE REPEAT RESULT ON THE ORIGINAL INSTRUMENT WAS 48.5 MG/DL. THE SURVEY ACCEPTABLE RANGE WAS 43-53 MG/DL WITH A MEAN OF 48 MG/DL. NO PATIENTS WERE INVOLVED IN THE EVENT. THE ISSUE WAS WITH PROFICIENCY MATERIAL ONLY. THE TOTAL PROTEIN REAGENT LOT NUMBER WAS 62675101. THE USER DECLINED A SERVICE VISIT AS THE INSTRUMENT WAS RUNNING PROPERLY. THE FIELD APPLICATION SPECIALIST DETERMINED THE CAUSE WAS UNKNOWN AND STATED SHE SUSPECTED A SAMPLING ISSUE WITH THE SAMPLES OR THE INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1