BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT CYCLOSPORINE

    MDR report key: 6098692 · Received November 14, 2016

    Report

    Report Number
    1415939-2016-00109
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Report Date
    May 11, 2017
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MKW
    UDI-DI
    00380740001315
    PMA / PMN Number
    K080751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION TO THE EVALUATION SUMMARY PREVIOUSLY DOCUMENTED. THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED. HOWEVER, NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(6). (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, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETURN MATERIAL WAS NOT AVAILABLE FROM THE CUSTOMER. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND FOR THE LOT IN QUESTION. 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 (B)(4), LOT 50164M500, WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY DECREASED CYCLOSPORINE RESULTS WHILE USING THE ARCHITECT CYCLOSPRORINE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING DATA: PATIENT 1: INITIAL 18.6, RETESTS 84, 66, 243, 194, PATIENT 2: INITIAL 164.4, RETESTS 41, 45, 68, 21, 57, 29.2, PATIENT 3: INITIAL 107.4, RETESTS 217, 60, 343, 36, 70, 21.7, PATIENT 4: INITIAL 4.8, RETESTS 36, 185, 133, 27, 53, 94.8, PATIENT 5: INITIAL 6, RETESTS 99, 82, 25, 43, 230, 126.9, PATIENT 6: INITIAL 49.1, RETESTS 25, 122, 265, 122, 67, 29.6, PATIENT 7: INTIAL 4.5 RETESTS 14.5, 39, 308, PATIENT 8: INITIAL 68.2, RETESTS 101, 263, PATIENT 9: INTIIAL 25.9, RETESTS 85, 223, 323. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752132 ARCHITECT CYCLOSPORINE CYCLOSPORINE MKW ABBOTT LABORATORIES 50164M500 00380740001315

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| LN (B)(4), SN (B)(4)