BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1633070 · Received March 17, 2010

    Report

    Report Number
    1823260-2010-01674
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF INITIAL REPORTER SENT REPORT TO FDA.

    Description of Event or Problem · 1

    USER REPORTED AN ABRUPT LOW SHIFT IN CONTROL RECOVERY FOR CKMB WHEN SWITCHING TO A NEW LOT OF CKMB REAGENT. TWO PATIENT SAMPLES WERE USED TO PERFORM A CORRELATION STUDY BETWEEN THE OLD AND NEW LOTS OF REAGENT. THE FOLLOWING PATIENT SAMPLE GAVE DISCREPANT RESULTS WHEN RUNNING THE CORRELATION STUDY THE PATIENT SAMPLE, INITIALLY TESTED WITH LOT 153685, GAVE A RESULT OF 5.30 NG/ML. THE SAMPLE TESTED WITH A NEW LOT, 155149, GAVE A RESULT OF 4.17 NG PER ML. SAMPLES WERE RUN FOR TROUBLESHOOTING PURPOSES ONLY, AND RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. 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 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1