BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE PRO-TRAC II TACROLIMUS ELISA KIT

    MDR report key: 4616031 · Received March 16, 2015

    Report

    Report Number
    2182595-2015-00001
    Event Type
    Malfunction
    Date Received
    March 16, 2015
    Report Date
    February 17, 2015
    Manufacturer
    DIASORIN, INC.
    Product Code
    MLM
    PMA / PMN Number
    P970025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CUSTOMER REPORTS OF INJURY OR ILLNESS HAVE BEEN RECEIVED. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DIASORIN THAT THIS PRODUCT CAUSED OR CONTRIBUTED TO ANY ALLEGED INJURY OR ILLNESS. THIS REPORT IS BEING SUBMITTED IN COMPLIANCE WITH THE MDR REGULATIONS.

    Description of Event or Problem · 1

    THE PRO-TRAC II TACROLIMUS ELISA KIT IS FAILING MULTIPLE INTERNAL SPECIFICATIONS: ABSORBANCE OF THE CALIBRATOR ZERO (OD), CALIBRATOR 1 (OD) - CALIBRATOR 5 (OD), CALIBRATOR 1 (OD) - CALIBRATOR ZERO(OD). DIASORIN INC HAS CONFIRMED THAT THE FAILURE MANIFESTS AS A DECREASE IN THE TOTAL ASSAY SIGNAL RESULTING IN A SHIFT IN THE CALIBRATION CURVE. THIS SHIFT MAY CAUSE DISCORDANT ELEVATED TACROLIMUS RESULTS TO BE REPORTED ON A PATIENT'S SAMPLE. EVALUATION SUMMARY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177294 THE PRO-TRAC II TACROLIMUS ELISA KIT ENZYME IMMUNOASSAY, TACROLIMUS MLM DIASORIN, INC. 131716/131717

    Patients

    Seq Age Sex Outcome Treatment
    1