BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 2003894 · Received March 1, 2011

    Report

    Report Number
    1823260-2011-01072
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIX
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR ALBUMIN GENERATION 2 (ALBUMIN), ALKALINE PHOSPHATASE GENERATION 2 AND UREA/BUN INVOLVING THREE PATIENT SAMPLES. OF THE DATA PROVIDED, ONLY THE ALBUMIN RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL ALBUMIN RESULT WAS 0.1 G/DL WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR QUESTIONED THE RESULT AND THE REPEAT RESULT WAS 2.5 G/DL WITH A DATA FLAG. THE SAMPLE WAS REPEATED ON ANOTHER COBAS C501 SERIAL NUMBER (B)(4) AND THE RESULT WAS 2.6 G/DL WITH A DATA FLAG. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE ALBUMIN REAGENT LOT NUMBER WAS 63305101. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS NOT BEING WASHED PROPERLY AND WAS NOT CENTERED IN RINSE STATION. HE PERFORMED A SAMPLE PROBE ADJUST AND ALIGNED RINSE STATION. TO VERIFY THE ANALYZER OPERATION, THE USER RAN QUALITY CONTROL ON ALL ASSAYS WITH RESULTS WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR