BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMIT 2000 CYCLOSPORIN SPECIFIC ASSAY

    MDR report key: 314476 · Received January 27, 2001

    Report

    Report Number
    2917681-2001-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2001
    Date of Event
    December 14, 2000
    Report Date
    January 26, 2001
    Manufacturer
    SYVA CO./DADE BEHRING, INC.
    Product Code
    MKW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ASSAY LABORATORY RESULTS INDICATED HIGH VARIABILITY IN DRUG CONCENTRATIONS AMONG REAGENT KITS FROM THE SAME ASSAY LOT AND SIGNIFICANTLY LOWER ASSAY RATES THAN EXPECTED. NO MEDICAL DECISIONS WERE MADE AS A RESULT OF THE LABORATORY RESULTS. UPON INVESTIGATION, BOTH CHAMBERS OF THE REAGENT CONTAINERS OF THE 3 RETURNED KITS SHOWED COMPROMISED (REDUCED) ACTIVITY IN COMPARISON TO RETAIN PRODUCTS. THE ENZYME CONJUGATE REAGENT EXHIBITED LOWER ENZYME ACTIVITY AND THE ANTIBODY REAGENT EXHIBITED HIGHER ABSORBANCE THAN RETAIN PRODUCT. THE ROOT CAUSE CONTINUES TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3535 EMIT 2000 CYCLOSPORIN SPECIFIC ASSAY IMMUNOSUPPRESSIVE DRUG ASSAY MKW SYVA CO./DADE BEHRING, INC. NA N2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other