BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1569445 · Received December 11, 2009

    Report

    Report Number
    1823260-2009-08385
    Event Type
    Malfunction
    Date Received
    December 11, 2009
    Date of Event
    November 22, 2009
    Report Date
    December 11, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REAGENT BULLETIN, WHICH INCLUDES THE NEW LOT USED BY THE CUSTOMER, HAS BEEN ISSUED COMMUNICATING THE CKMB REAGENT HAS BEEN RESTANDARDIZED.

    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 REC'D WHEN RUNNING THE CORRELATION STUDIES. SAMPLES WERE TESTED WITH THE NEW LOT ON (B)(6) 2009. SAMPLE 1, OLD LOT GAVE 3.26; NEW LOT GAVE 2.4 NG PER ML. SAMPLE 2, OLD LOT GAVE 3.25; NEW LOT GAVE 2.4 NG PER ML. SAMPLE 3, OLD LOT GAVE 7.6; NEW LOT GAVE 6.6 NG PER ML. SAMPLE 4, OLD LOT GAVE 5.95; NEW LOT GAVE 5.09 NG PER ML. SAMPLE 5, OLD LOT GAVE 3.24; NEW LOT GAVE 2.42 NG PER ML. SAMPLE 6, OLD LOT GAVE 3.45; NEW LOT GAVE 2.5 NG PER ML. SAMPLE 7, OLD LOT GAVE 3.79; NEW LOT GAVE 3.06 NG PER ML. SAMPLE 8, OLD LOT GAVE 3.15; NEW LOT GAVE 2.33 NG PER ML. SAMPLES WERE RUN FOR TROUBLESHOOTING PURPOSES ONLY, AND RESULTS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 RACK SYSTEM IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E411

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK