BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1550396 · Received November 20, 2009

    Report

    Report Number
    1823260-2009-08002
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    November 3, 2009
    Report Date
    November 20, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JHS
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. PATIENT SAMPLES WERE USED TO PERFORM CORRELATION STUDIES BETWEEN THE OLD AND NEW LOTS OF REAGENT. THE OLD LOT IS 153685. THE NEW LOT IS 155149. THE FOLLOWING DISCREPANT PATIENT RESULTS WERE RECEIVED WHEN RUNNING THE CORRELATION STUDIES: SAMPLES WERE TESTED WITH THE NEW LOT ON (B) (6) 2009. OF THE DATA PROVIDED, ON RESULTS WAS DISCREPANT. RESULT FROM OLD LOT GAVE 2.71 NG PER ML NEW GAVE 2.19 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 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE JHS ROCHE DIAGNOSTICS 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK