BEUDAMED
    FDA Adverse Event Summary report: N

    STA-R EVOLUTION

    MDR report key: 4872143 · Received June 25, 2015

    Report

    Report Number
    8043723-2015-00002
    Date Received
    June 25, 2015
    Date of Event
    May 23, 2015
    Report Date
    June 24, 2015
    Manufacturer
    DIAGNOSTICA STAGO GENNEVILLIERS
    Product Code
    GKP
    PMA / PMN Number
    K093167
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ISSUE HAS BEEN COMMUNICATED TO THE MANUFACTURER, DIAGNOSTICA STAGO (B)(4) AND IS UNDER INVESTIGATION. AT THIS TIME, IT APPEARS THAT THIS WAS AN ISOLATED EVENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE RELEVANT INFORMATION BECOMES AVAILABLE. (B)(4).

    Additional Manufacturer Narrative · 1

    DIAGNOSTICA STAGO HAS INVESTIGATED THE INCIDENT THAT OCCURRED ON (B)(6) 2015 ON STA-R EVOLUTION (SN (B)(4)) AND WAS REPORTED TO DIAGNOSTICA STAGO INC. (DSI) HOTLINE ON (B)(6) 2015. SEVERAL ERRORS WERE FOUND IN THE ERROR LOG DURING THE FIELD SERVICE ENGINEER'S (FSE) VISIT ((B)(6) 2015) FOR AN UNRELATED ISSUE. THOSE ERROR WARNINGS WERE: - WASTE BOTTLE WAS FULL - INTERMEDIATE RESERVOIR WAS NOT FILLING - INSUFFICIENT VACUUM. THE SYSTEM FILES HAVE BEEN INVESTIGATED BY THE MANUFACTURER'S R&D DEPARTMENT IN FRANCE. THE R&D INVESTIGATORS STATED THAT THERE IS NO LINK BETWEEN THE ERRONEOUS RESULT OBSERVED IN THE INCIDENT AND THE KIND OF ERRORS FOUND IN THE ERROR LOG. IN PARTICULAR, THE CHRONOMETRIC CURVE OF THE CONCERNED ERRONEOUS RESULT WAS CHECKED AND WAS WITHOUT ISSUE. THE R&D INVESTIGATOR DID NOT IDENTIFY ANY MALFUNCTION OF THE ANALYZER THAT WAS RELATED TO THE ERRONEOUS RESULT. DIAGNOSTICA STAGO HAS CONCLUDED THAT THIS IS AN ISOLATED CASE WHOSE ROOT CAUSE COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THE CUSTOMER HAS CONFIRMED THAT THE TREATMENT (FRESH FROZEN PLASMA) HAD NO IMPACT ON THE PATIENT'S HEALTH CONDITION. DIAGNOSTICA STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS EVENT.

    Description of Event or Problem · 1

    ON 05/26/2015, DIAGNOSTICA STAGO, INC. RECEIVED A CALL FROM THE CUSTOMER ((B)(6) MEDICAL CENTER) INDICATING THE RELEASE OF AN ERRONEOUS PT RESULT OF 33.8 ON (B)(6) 2015. THE CUSTOMER FOUND THIS RESULT TO BE ERRONEOUS AS OF (B)(6) 2015 WHEN THE RESULT WAS PROMPTED FOR A RE-TEST BY THE PHYSICIAN. THE RE-TEST RESULT WAS 15.7. THE SAMPLE WAS STORED IN THE FREEZER AT -32 DEGREE C. THE PATIENT RECEIVED ONE UNIT OF FRESH FROZEN PLASMA (FFP) IN RESPONSE TO THE ERRONEOUS RESULT THAT WAS RELEASED. THIS DID NOT HAVE A NEGATIVE IMPACT ON THE PATIENT. A FIELD SERVICE ENGINEER WAS AT THE ACCOUNT ON 05/24/2015 FOR AN UNRELATED ISSUE. NEITHER THE ACCOUNT NOR DIAGNOSTICA STAGO WERE AWARE OF THE ERRONEOUS RESULT AT THIS TIME. A CHECK OF THE ERROR LOG INDICATED THE FOLLOWING ERRORS: WASTE BOTTLE FULL, INTERMEDIATE RESERVOIR NOT FILLING, AND INSUFFICIENT VACUUM. THE FIELD SERVICE ENGINEER CLEANED AND REPLACED THE WASTE BOTTLE.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411143 STA-R EVOLUTION IVD COAGULATION DEVICE/INSTRUMENT GKP DIAGNOSTICA STAGO GENNEVILLIERS 58978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other