BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1810937 · Received August 23, 2010

    Report

    Report Number
    1823260-2010-05008
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CJW
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED 43 ERRONEOUS ALBUMIN RESULTS FROM THE COBAS 6000 C501 MODULE. THE CUSTOMER STATED THAT THE ERRONEOUS RESULTS WERE GENERATED AFTER ENCOUNTERING A PROBLEM WITH A REAGENT PROBE ON THE ANALYZER. THE CUSTOMER SAID THAT THE PROBE WAS HITTING THE RINSE STATION. THE CUSTOMER CHANGED THE PROBE AND STATED THAT THE SYSTEM RAN FINE ALL DAY. THE ERRONEOUS RESULTS OCCURRED AFTER THE SAMPLE PROBE WAS REPLACED. REPEAT RESULTS WERE GENERATED AFTER SERVICING BY THE FIELD SERVICE REPRESENTATIVE. FOR PATIENT 1 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.7 G/DL. FOR PATIENT 2 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.3 G/DL. FOR PATIENT 3 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.2 G/DL. FOR PATIENT 4 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.9 G/DL. FOR PATIENT 5 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 6 THE INITIAL ALBUMIN WAS 0.5 G/DL AND THE REPEAT RESULT WAS 4.6 G/DL. FOR PATIENT 7 THE INITIAL ALBUMIN WAS 0.5 G/DL AND THE REPEAT RESULT WAS 4.7 G/DL. FOR PATIENT 8 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 9 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.7 G/DL. FOR PATIENT 10 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 11 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.7 G/DL. FOR PATIENT 12 THE INITIAL ALBUMIN WAS 0.5 G/DL AND THE REPEAT RESULT WAS 4.6 G/DL. FOR PATIENT 13 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 2.3 G/DL. FOR PATIENT 14 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.2 G/DL. FOR PATIENT 15 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.5 G/DL. FOR PATIENT 16 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.1 G/DL. FOR PATIENT 17 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.8 G/DL. FOR PATIENT 18 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.6 G/DL. FOR PATIENT 19 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 1.8 G/DL. FOR PATIENT 20 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 21 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 22 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 23 THE INITIAL ALBUMIN WAS 0.5 G/DL AND THE REPEAT RESULT WAS 4.5 G/DL. FOR PATIENT 24 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 4.1 G/DL. FOR PATIENT 25 THE INITIAL ALBUMIN WAS 0.5 G/DL AND THE REPEAT RESULT WAS 4.5 G/DL. FOR PATIENT 26 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.9 G/DL. FOR PATIENT 27 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 1.9 G/DL. FOR PATIENT 28 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.6 G/DL. FOR PATIENT 29 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.6 G/DL. FOR PATIENT 30 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.1 G/DL. FOR PATIENT 31 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.8 G/DL. FOR PATIENT 32 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.0 G/DL. FOR PATIENT 33 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.1 G/DL. FOR PATIENT 34 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 2.1 G/DL. FOR PATIENT 35 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.5 G/DL. FOR PATIENT 36 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 1.9 G/DL. FOR PATIENT 37 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.3 G/DL. FOR PATIENT 38 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 1.9 G/DL. FOR PATIENT 39 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 3.1 G/DL. FOR PATIENT 40 THE INITIAL ALBUMIN WAS 0.2 G/DL AND THE REPEAT RESULT WAS 2.2 G/DL. FOR PATIENT 41 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.9 G/DL. FOR PATIENT 42 THE INITIAL ALBUMIN WAS 0.4 G/DL AND THE REPEAT RESULT WAS 3.7 G/DL. FOR PATIENT 43 THE INITIAL ALBUMIN WAS 0.3 G/DL AND THE REPEAT RESULT WAS 2.6 G/DL. THE ALBUMIN REAGENT LOT NUMBER WAS 62566601. ALL INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. CORRECTED REPORTS WERE ISSUED WITH THE REPEAT RESULTS. THE CUSTOMER STATED THAT NO PATIENTS WERE AFFECTED BY THE ERRONEOUS RESULTS AND THAT NO CHANGE TO MEDICATIONS OR TREATMENTS OCCURRED DUE TO THE ERRONEOUS RESULTS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THERE WAS A FLUIDICS FAILURE AND A PROBLEM WITH THE SAMPLE AND REAGENT PROBES. THE FIELD SERVICE REPRESENTATIVE PERFORMED CORRECTIVE MAINTENANCE, CHECKED THE SAMPLE AND REAGENT PROBES, BLEACHED THE SAMPLE AND REAGENT PROBE LINES, AND CHECKED THE BATH WATER. DIAGNOSTICS AND PRECISION TESTS WERE PERFORMED AND WERE DETERMINED TO BE ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER CJW ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1