BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 311

    MDR report key: 1980994 · Received February 8, 2011

    Report

    Report Number
    1823260-2011-00677
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CIX
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE ALBUMIN RESULTS FOR TWO PATIENT SAMPLES. OF THE PROVIDED DATA, THE RESULT FOR ONE SAMPLE WAS DISCREPANT. ALL RESULTS ARE IN G/DL. THE INITIAL RESULT WAS 4.0 AND THE REPEAT RESULT WAS 2.7. THE USER STATED THE HIGH RESULT WAS NOTICED BECAUSE THE GLOBULIN CALCULATION GENERATED A LOW RESULT OF 0.4. NO UNIT OF MEASURE WAS PROVIDED. THIS WAS FLAGGED IN THE COMPUTER SYSTEM PROMPTING THE REPEAT TESTING. THE INITIAL RESULT FOR ALBUMIN WAS RELEASED AND THE PATIENT WAS NOT HARMED BASED ON THE INITIAL RESULT. THE ALBUMIN REAGENT LOT NUMBER WAS 62171501. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE ISSUE. HE CHECKED THE PROBE ALIGNMENT AND VERIFIED THE ANALYZER OPERATION BY HAVING THE USER RUN A PRECISION CHECK ON A PATIENT SAMPLE AND QUALITY CONTROL MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 311 CLINICAL CHEMISTRY ANALYZER CIX ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1