BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL PROTEIN GEN.2

    MDR report key: 2133637 · Received June 20, 2011

    Report

    Report Number
    1823260-2011-03338
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE TOTAL PROTEIN RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS C501 ANALYZER SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 0.3 G/DL AND WAS REPORTED OUTSIDE THE LABORATORY. WHEN THE USER RECEIVED ANOTHER SAMPLE FROM THE SAME PATIENT AND TESTED IT, THE SYSTEM ISSUED AN ALERT BECAUSE THE CURRENT RESULT DID NOT MATCH THE RESULT FROM THE PREVIOUS SAMPLE. THE USER PULLED THE ORIGINAL SAMPLE AND REPEATED TESTING ON (B)(6) 2011 WITH A RESULT OF 8.0 G/DL. PER LABORATORY PROTOCOL, THE USER FILED A CORRECTED REPORT. THE PATIENT WAS NOT ADVERSELY AFFECTED. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FLUIDIC FAILURE DUE TO AN UNKNOWN MATERIAL FOUND FLOATING IN THE ORIGINAL SAMPLE TUBE. HE TAUGHT THE USER THE IMPORTANCE OF PRE-ANALYTIC SAMPLE HANDLING AND REPLACED THE SAMPLE PROBE AS A PREVENTIVE MEASURE. TO VERIFY THE ANALYZER OPERATION, THE USER RAN CALIBRATION, QUALITY CONTROL, AND PRECISION TESTING WITH RESULTS WITHIN THEIR SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL PROTEIN GEN.2 BIURET (COLORIMETRIC), TOTAL PROTEIN CEK ROCHE DIAGNOSTICS NA 63701701

    Patients

    Seq Age Sex Outcome Treatment
    1