BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 3734577 · Received April 8, 2014

    Report

    Report Number
    1415939-2014-00087
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Report Date
    March 21, 2014
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4). AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, A REVIEW OF LABELING AND ACCURACY TESTING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ACCURACY TESTING OF THE REAGENT LOT WITH TWO LEVELS OF AN INTERNAL PANEL (EACH LEVEL CONTAINS A KNOWN CONCENTRATION OF THE CYCLOSPORINE ANALYTE) MET ALL SPECIFICATIONS. COMPLAINT INFORMATION REASONABLY SUGGESTS THE ASSAY IS PERFORMING AS INTENDED, AND NO MALFUNCTION OF THE DEVICE OCCURRED. BASED ON THE AVAILABLE INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A FALSELY ELEVATED CYCLOSPORINE RESULT FOR ONE PATIENT ON THE ARCHITECT I1000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 1300 UG/L (SUSPECT FALSELY ELEVATED, QUESTIONED BY THE DOCTOR). 1:4 DILUTION AND OBTAINED <800 UG/L WITH A CNRL FLAG, REPEATED THE SAMPLE NEAT 1000 UG/L. 1:4 DILUTION 50 UG/L (THE DILUTION FACTOR WAS NOT KEYED IN HOWEVER), THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210579 ARCHITECT CYCLOSPORINE CYCLOSPORINE MKW ABBOTT LABORATORIES 33387M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER| LN 01L86-01 SN (B)(4)| ARCHITECT I1000SR ANALYZER| LN 01L86-01 SN (B)(4)