BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1553558 · Received November 19, 2009

    Report

    Report Number
    1823260-2009-07959
    Event Type
    Malfunction
    Date Received
    November 19, 2009
    Date of Event
    May 22, 2009
    Report Date
    November 19, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER STATED, THEY FAILED PROFICIENCY TESTING FOR PRO-BNP. SAMPLE 1 TESTED ON (B) (6) 2009 AND (B) (6) 2009 GAVE A RESULT OF 870 PG PER ML WITH AN EXPECTED RESULT RANGE OF 908-1127 PG PER ML. SAMPLE 2 TESTED ON (B) (6) 2009 AND (B) (6) 2009 GAVE A RESULT OF 61 PG PER ML WITH AN EXPECTED RESULT RANGE OF 70-83 PG PER ML. SAMPLE 3 TESTED ON (B) (6) 2009 AND (B) (6) 2009 GAVE A RESULT OF 589 PG PER ML WITH AN EXPECTED RESULT RANGE OF 596-741 PG PER ML. NO ERRONEOUS RESULTS WERE GENERATED FOR PT SAMPLES. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A CAUSE AND REPLACED THE MEASURING CELL AS PART OF PREVENTIVE MAINTENANCE. TO VERIFY THE ANALYZER PERFORMANCE, HE RAN PERFORMANCE TESTS WITH ACCEPTABLE RESULT. CALIBRATION AND QC RESULT HAVE BEEN ACCEPTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK