BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 2991374 · Received March 6, 2013

    Report

    Report Number
    1415939-2013-00092
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS COMPLETED IN ORDER TO INVESTIGATE THIS ISSUE. REVIEW OF TICKET TRENDING AND LOT SEARCH DATA DID NOT IDENTIFY ATYPICAL COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. ACCURACY TESTING WAS COMPLETED USING RETAINED KITS OF REAGENT LOT 16054M500. ACCEPTANCE CRITERIA WERE MET, WHICH INDICATES ACCEPTABLE PRODUCT PERFORMANCE. A DEFICIENCY WAS NOT IDENTIFIED AS PANEL TESTING SHOWS THAT THE LIKELY CAUSE LOT PERFORMS PER SPECIFICATION. BASED ON THE EVALUATION RESULTS, NO MALFUNCTION OF THE LOT IN QUESTION WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE (SPECIMEN ?) GENERATED HIGHER THAN EXPECTED RESULTS OF 210 AND 230 NG/ML FOR THE ARCHITECT CYCLOSPORINE ASSAY. THE PATIENT SAMPLE HAD PREVIOUSLY (2 DAYS EARLIER) GENERATED AN EXPECTED RESULT OF 130 NG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95619 ARCHITECT CYCLOSPORINE MKW ABBOTT LABORATORIES 16054M500

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 ANALYZER 03M74-01 SN (B)(4)| ARCHITECT I2000 ANALYZER 03M74-01 SN (B)(4)