BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORZYME

    MDR report key: 276187 · Received May 1, 2000

    Report

    Report Number
    1415939-2000-00003
    Event Type
    Injury
    Date Received
    May 1, 2000
    Date of Event
    March 15, 2000
    Report Date
    April 28, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PRE-LUNG TRANSPLANT PT WHO WAS PREVIOUSLY NEGATIVE FOR CORZYME IS NOW REPEAT REACTIVE WITH TWO DIFFERENT SAMPLES (3/15/00 AND 3/24/00). THE DOCTOR QUESTIONED THE RESULTS BECAUSE THE PT HAS BEEN PREVIOUSLY NEGATIVE FOR "HBC", TESTING WAS DONE WITHIN THE LAST 6 MONTHS AT ANOTHER FACILITY. THE PT IS AT END STAGE CYSTIC FIBROSIS AWAITING A LUNG TRANSPLANT. THE DECISION TO TRANSPLANT WAS DELAYED DUE TO THE RESULTS OBTAINED. THE PT IS STILL WAITING FOR A LUNG TRANSPLANT DUE TO REASONS OTHER THAN THE POSITIVE CORZYME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORZYME EIA FOR DETECTION OF HEPATITIS B CORE ANTIBODY LOM ABBOTT LABORATORIES NA 59910M101

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other