BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2955237 · Received February 11, 2013

    Report

    Report Number
    1415939-2013-00038
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 24, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. IT WAS NOTED THAT SAMPLE HANDLING ISSUES WERE IDENTIFIED AT THE CUSTOMER SITE. AN ACCURACY TESTING PROTOCOL WAS EXECUTED USING LOT 18265M500; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT CYCLOSPORINE REAGENT LIST NUMBER 01L75, LOT NUMBER 18265M500, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED DISCREPANT CYCLOSPORINE RESULTS WHILE USING THE ARCHITECT CYCLOSPORINE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS (NG/ML): SID (B)(6): INITIAL 245.4, RETEST 113.5; COMPARED TO MASS SPEC RESULTS: 60, 70 NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58389 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 18265M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER| LN01L86-01, SN (B)(4)| ARCHITECT I1000SR ANALYZER| LN01L86-01, SN (B)(4)