BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYCLOSPORINE

    MDR report key: 420711 · Received October 4, 2002

    Report

    Report Number
    1823260-2002-00328
    Event Type
    Injury
    Date Received
    October 4, 2002
    Date of Event
    September 3, 2002
    Report Date
    September 4, 2002
    Manufacturer
    ROCHE - GMBH
    Product Code
    MKW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES THAT THEY ARE SEEING LOW RESULTS. THEY WERE EXPECTING A RESULT OF 1400 NG/ML BUT RECEIVED 800-900 NG/ML. THE PATIENTS RECEIVED AN INCREASED DOSAGE OF DRUG AND EXHIBITED TOXIC SYMPTOMS. NO FURTHER INFORMATION WAS AVAILABLE FROM THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLOSPORINE IN VITRO DIAGNOSTIC REAGENT MKW ROCHE - GMBH NA 630312

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening