BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1569596 · Received December 2, 2009

    Report

    Report Number
    1823260-2009-08152
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 8, 2009
    Report Date
    December 2, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER EXPERIENCED AN ISSUE WITH LOW CONTROL RECOVERY FOR CKMB WHEN SWITCHING TO A NEW LOT OF CKMB REAGENT. PT SERUM 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: SAMPLE 1, OLD LOT GAVE 2.8; NEW LOT GAVE 1.7 NG PER ML. SAMPLE 2, OLD LOT GAVE 2.1; NEW LOT GAVE 1.5 NG PER ML. SAMPLE 3, OLD LOT GAVE 2.6; NEW LOT GAVE 2.1 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.

    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