BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX TACROLIMUS II REAGENT PACK

    MDR report key: 950617 · Received November 20, 2007

    Report

    Report Number
    1415939-2007-00254
    Event Type
    Other
    Date Received
    November 20, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MLM
    PMA / PMN Number
    P970007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER IS CONTINUING TO RUN CORRELATION STUDIES AND WILL BE SENDING THE DATA TO ABBOTT FOR FURTHER REVIEW. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN ABBOTT PRODUCT INFO LETTER REGARDING A NEW LOT OF MICROPARTICLES BEING USED TO MANUFACTURE IMX TACROLIMUS II REAGENT LOTS. THE CUSTOMER PERFORMED PATIENT CORRELATION STUDIES BETWEEN THE OLD AND NEW REAGENT LOTS AND STATED THEY NOTED UP TO A 50% DOWNWARD SHIFT IN RESULTS, WHICH IS LOWER THAN WHAT IS STATED IN THE PRODUCT INFORMATION LETTER REGARDING POTENTIAL SHIFTS IN BIO-RAD QC RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMX TACROLIMUS II REAGENT PACK MEIA FOR THE MEASUREMENT OF TACROLIMUS MLM ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR IMX ANALYZER LIST # 8389-01