BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA COMPACT

    MDR report key: 5820444 · Received July 25, 2016

    Report

    Report Number
    8043723-2016-00001
    Event Type
    Injury
    Date Received
    July 25, 2016
    Date of Event
    July 14, 2015
    Report Date
    June 13, 2025
    Manufacturer
    DIAGNOSTICA STAGO
    Product Code
    JPA
    PMA / PMN Number
    K093167
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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. IT IS ALLEGED BY THE PATIENT THAT ERRONEOUS PT AND INR RESULTS BY THE STAGO INSTRUMENTATION MAY HAVE LED TO UNSUITABLE THERAPY FOLLOWED BY SURGICAL/MEDICAL INTERVENTION TO REMOVE FLUID IN OR AROUND THE PATIENT'S LEFT LUNG REGION. THIS PROCEDURE TOOK PLACE ON (B)(6) 2015. DIAGNOSTICA STAGO INC. WAS NOT MADE AWARE UNTIL (B)(6) 2016. INVESTIGATION TO BE DETERMINED.

    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. IT IS ALLEGED BY THE PATIENT THAT ERRONEOUS PT AND INR RESULTS BY THE STAGO INSTRUMENTATION MAY HAVE LED TO UNSUITABLE THERAPY FOLLOWED BY SURGICAL/MEDICAL INTERVENTION TO REMOVE FLUID IN OR AROUND THE PATIENT'S LEFT LUNG REGION. THIS PROCEDURE TOOK PLACE ON (B)(6) 2015. DIAGNOSTICA STAGO INC. WAS NOT MADE AWARE UNTIL 7/11/2016. SUPPLEMENTAL REQUESTED BY (B)(4).

    Description of Event or Problem · 0

    THROUGH A LEGAL PETITION RECEIVED BY DIAGNOSTICA STAGO INC. ON (B)(6) 2016, THE FACILITY BECAME AWARE OF AN EVENT THAT OCCURRED THE PREVIOUS YEAR ON OR ABOUT (B)(6) 2015. A PATIENT AT THE (B)(6) MEDICAL CENTER IN (B)(6) ALLEGES THAT THE RESULTS GENERATED BY THE STAGO INSTRUMENTATION FOR PT AND INR WERE ERRONEOUS AND LED TO UNSUITABLE THERAPY WHICH WAS FOLLOWED BY SURGICAL INTERVENTION TO REMOVE FLUID AROUND THE PATIENT'S LEFT LUNG REGION.

    Description of Event or Problem · 0

    THROUGH A LEGAL PETITION RECEIVED BY DIAGNOSTICA STAGO INC. ON JULY 11TH, 2016, THE FACILITY BECAME AWARE OF AN EVENT THAT OCCURRED THE PREVIOUS YEAR ON OR ABOUT (B)(6) 2015. A PATIENT AT THE (B)(6) MEDICAL CENTER IN (B)(6) ALLEGES THAT THE RESULTS GENERATED BY THE STAGO INSTRUMENTATION FOR PATIENT AND INR WERE ERRONEOUS AND LED TO UNSUITABLE THERAPY WHICH WAS FOLLOWED BY SURGICAL INTERVENTION TO REMOVE FLUID AROUND THE PATIENT'S LEFT LUNG REGION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471920 STA COMPACT STA COMPACT JPA DIAGNOSTICA STAGO IVD COAGULATION DEVICE/INSTRUMENT /

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Life Threatening| H| R| O