BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1549635 · Received November 12, 2009

    Report

    Report Number
    1823260-2009-07780
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    October 11, 2009
    Report Date
    November 12, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER CHANGED LOTS OF CKMB REAGENT AND NOTICED HIS LEVEL 3 QC WAS OUT LOW. HE STATED HE ALSO PERFORMED A PT CORRELATION AND THE RESULTS WERE LOWER ON THE NEW LOT. OF THE DATA PROVIDED, TWO RESULTS WERE DISCREPANT. SAMPLE 1 RESULT ON LOT # 153686 WAS 3.49 NG PER ML, REPEAT RESULT USING LOT 155150 WAS 2.41 NG PER ML. SAMPLE 2 RESULT ON LOT# 153686 WAS 2.86 NG PER ML, REPEAT RESULT USING LOT 155150 WAS 1.89 NG PER ML. THE USER WAS VALIDATING THE NEW LOT NUMBER, SO NO PT SAMPLES WERE TESTED OTHER THAN THE CORRELATION STUDY. THE USER ALSO RAN CONTROLS ON THE OTHER INSTRUMENT (B)(4) USING THE NEW LOT OF REAGENT AND THE CONTROL WAS OUTSIDE OF THE ACCEPTABLE RANGE LOW. THE FIELD SERVICE REP DETERMINED THE MEASURING CELL WAS THE CAUSE AND REPLACED IT. HE PERFORMED A SYSTEM VOLUME CHECK, PMT ADJUSTMENT AND A CELL BLANK CALIBRATION. TO VERIFY THE ANALYZER OPERATION, HE RAN PERFORMANCE TESTS, CALIBRATION AND QC WITHIN RESULTS WITHIN SPECIFICATION.

    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