BEUDAMED
    FDA Adverse Event Summary report: N

    STA COMPACT

    MDR report key: 3938888 · Received June 16, 2014

    Report

    Report Number
    2245451-2014-00001
    Date Received
    June 16, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    DIAGNOSTICA STAGO, GENNEVILLIERS
    Product Code
    GKP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, DIAGNOSTICA STAGO, INC (DSI) RECEIVED INFORMATION THAT ERRONEOUS RESULTS WERE CREATED FOR PT, PTT AND D-DIMER TESTS. THE INSTRUMENT WAS A STA COMPACT (SERIAL NUMBER (B)(4)). A SERVICE ENGINEER SERVICED THE INSTRUMENT ON THE SAME DAY. THE CUSTOMER WAS ABLE TO REPRODUCE THE FAILURE WHILE THE SERVICE ENGINEER WAS ON SITE. ON (B)(4) 2014, DSI RECEIVED ADDITIONAL INFORMATION FROM THE LABORATORY MANAGER INDICATING A TOTAL OF 18 PATIENTS WERE AFFECTED PRIOR TO THE PROBLEM BEING REPORTED. OF THESE, FOUR WERE OVER MEDICATED DUE TO ERRONEOUS RESULTS. ALL FOUR PATIENTS HAD THEIR MEDICATION READJUSTED AND APPEAR TO HAVE EXPERIENCED NO INJURY. TWO PATIENTS HAD D-DIMERS PERFORMED FOR SUSPECTED PULMONARY EMBOLISM. BASED UPON THE ERRONEOUS RESULTS, CT SCANS WERE NOT INITIALLY PERFORMED. CT SCANS WERE PERFORMED AFTER THE ERROR WAS DETECTED AND REPORTED. REF # MFR 8043723-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353459 STA COMPACT IVD COAGULATION DEVICE/INSTRUMENT GKP DIAGNOSTICA STAGO, GENNEVILLIERS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other