BEUDAMED
    FDA Adverse Event Death Summary report: N

    STA-R EVOLUTION

    MDR report key: 6785114 · Received August 10, 2017

    Report

    Report Number
    8043723-2017-00002
    Event Type
    Death
    Date Received
    August 10, 2017
    Date of Event
    July 13, 2017
    Report Date
    July 17, 2017
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    UDI-DI
    03607450589788
    PMA / PMN Number
    K082675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO, S.A.S. GENNEVILLIERS (MANUFACTURER) UNDER EXEMPTION NUMBER E2012018. H3 OTHER TEXT : EVALUATION PERFORMED BY THE DISTRIBUTOR

    Additional Manufacturer Narrative · 0

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO, S.A.S. GENNEVILLIERS (MANUFACTURER) UNDER EXEMPTION NUMBER E2012018. PLEASE REFER TO (MDR FOLLOW-UP REPORT 1 - SEPTEMBER 21 2017) FOR INFORMATION REGARDING FOLLOW-UP #1.

    Description of Event or Problem · 0

    ON (B)(6) 2017, DIAGNOSTICA STAGO INC. BECAME AWARE OF A DEATH AT (B)(6). THE FEMALE PATIENT EXPIRED ON OR ABOUT (B)(6) 2017. THE PATIENT'S PT, PTT, AND D-DIMER WERE TESTED USING THE STAGO ANALYZER [STA-R EVOLUTION, SERIAL NUMBER (B)(4)]. AT THIS TIME THERE IS NO EVIDENCE OF AN INSTRUMENT MALFUNCTION, NOR IS THERE A CLEAR CONNECTION BETWEEN THE PATIENT'S DEATH AND THE STAGO TESTING. THE INVESTIGATION IS CONTINUING; FULL DETAILS AND ADDITIONAL DATA ARE STILL BEING RECEIVED BY THE DESIGNATED COMPLAINT HANDLING UNIT. A SUPPLEMENTARY/ FOLLOW-UP REPORT (OR REPORTS) WILL BE SUBMITTED AS PERTINENT INFORMATION BECOMES AVAILABLE. THE INVESTIGATION FILE IS BEING DOCUMENTED UNDER REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565512 STA-R EVOLUTION EVOLUTION JPA DIAGNOSTICA STAGO S.A.S. IVD COAGULATION DEVICE/INSTRUMENT 03607450589788

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death