BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STA COMPACT

    MDR report key: 4730510 · Received April 24, 2015

    Report

    Report Number
    2245451-2015-00001
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    March 26, 2015
    Report Date
    March 27, 2015
    Manufacturer
    DIAGNOSTICA STAGO
    Product Code
    GKP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, DIAGNOSTICA STAGO, INC. RECEIVED A CALL FROM THE CUSTOMER (B)(6) INDICATING THE RELEASE OF AN ERRONEOUS RESULT FOR PT ON (B)(6) 2015. THE RESULT WAS GENERATED ON AN STA COMPACT SYSTEM, SERIAL NUMBER (B)(4). THIS WAS REPORTED TO BE AN UNDER ESTIMATED TEST RESULT; OTHER TESTING SHOWED THAT THE PATIENT HAD A HIGH PT VALUE. THE PATIENT IS UNDER VKA THERAPY (COUMADIN); S/HE DID RECEIVE TREATMENT BASED ON THE ERRONEOUS RESULT BUT DID NOT SUFFER ANY INJURY AS A RESULT (ACCORDING TO THE CUSTOMER REPRESENTATIVE). A SERVICE ENGINEER ARRIVED AT THE FACILITY THE SAME DAY THAT THE CALL WAS RECEIVED ((B)(6) 2015), BUT COULD NOT REPRODUCE THE ISSUE NOR DID THE SERVICE ENGINEER NEED TO REPLACE ANY PARTS. REFERENCE MFR # 8043723-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274299 STA COMPACT IVD COAGULATION DEVICE/INSTRUMENT GKP DIAGNOSTICA STAGO

    Patients

    Seq Age Sex Outcome Treatment
    1