BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2421967 · Received January 19, 2012

    Report

    Report Number
    1415939-2012-00015
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 12, 2012
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    NO RETURNED MATERIALS FROM THE CUSTOMER SITE WERE USED DURING THIS EVALUATION. A PRECISION RUN WAS PERFORMED WITH REAGENT LOT 07011M500. (B)(4). AN ACCURACY RUN WAS ALSO PERFORMED USING TWO SEPARATE LOTS OF PANEL SAMPLES (LOTS AAM223 AND AAC442). ALL GENERATED VALUES MET ACCEPTANCE CRITERIA FOR THEIR RESPECTIVE MEAN FOR EACH LOT. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT CYCLOSPORINE ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. BASED ON THE RESULTS OF THE CURRENT EVALUATION, THE ARCHITECT CYCLOSPORINE ASSAY IS PERFORMING AS INTENDED AND NO ADDITIONAL PRODUCT ISSUES WERE FOUND. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PATIENT SAMPLE GENERATED ARCHITECT CYCLOSPORINE ASSAY RESULTS OF 120, 175, AND 145 NG/ML. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 07011M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I2000SR LN: 03M75-02 SN: (B)(4)| ARCH I2000SR LN: 03M75-02 SN: (B)(4)