BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1550415 · Received November 20, 2009

    Report

    Report Number
    1823260-2009-08009
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    November 1, 2009
    Report Date
    November 20, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED ISSUE WITH LOW CONTROL RECOVERY FOR CKMB WHEN SWITCHING TO A NEW LOT OF CKMB REAGENT. PT SAMPLES WERE USED TO PERFORM CORRELATION STUDIES BETWEEN THE OLD AND NEW LOTS OF REAGENT. THE OLD LOT IS 153686. THE NEW LOT IS 155150. THE FOLLOWING DISCREPANT PT RESULTS WERE RECEIVED WHEN RUNNING THE CORRELATION STUDIES. SAMPLES WERE TESTED WITH THE OLD LOT ON A DIFFERENT E MODULE (B) (4), AT CUSTOMER SITE. SAMPLE 1, NEW LOT GAVE 1.45; OLD LOT GAVE 2.14 GAVE NG PER ML. SAMPLE 2, NEW LOT GAVE 2.28; OLD LOT GAVE 3.32 NG PER ML. SAMPLE 3, NEW LOT GAVE 1.89; OLD LOT GAVE 3.01 NG PER ML. SAMPLE 4, NEW LOT GAVE 2.08; OLD LOT GAVE 3.07 NG PER ML. SAMPLE 5, NEW LOT GAVE 8.19; OLD LOT GAVE 9.33 NG PER ML. SAMPLE 6, NEW LOT GAVE 2.53; OLD LOT GAVE 3.72 NG PER ML. SAMPLE 7, NEW LOT GAVE 4.34; OLD LOT GAVE 5.47 NG PER ML. SAMPLE 8, NEW LOT GAVE 3.14; OLD LOT GAVE 4.19 NG PER ML. SAMPLE 9, NEW LOT GAVE 1.83; OLD LOT GAVE 2.88 NG PER ML. SAMPLE 10, NEW LOT GAVE 3.18; OLD LOT GAVE 4.16 NG PER ML. SAMPLES WERE RUN FOR TROUBLESHOOTING PURPOSES ONLY, AND RESULTS WERE NOT REPORTED. A REAGENT BULLETIN, WHICH INCLUDES THE NEW LOT USED BY THE CUSTOMER, HAS BEEN ISSUED COMMUNICATING THE CKMB REAGENT HAS BEEN RESTANDARDIZED. THE MEDICAL RISK ASSOCIATED WITH THIS ISSUE IS REMOTE.

    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