BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA-R EVOLUTION

    MDR report key: 7756303 · Received August 7, 2018

    Report

    Report Number
    8043723-2018-00002
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    July 3, 2018
    Report Date
    December 18, 2018
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K082675
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    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. STAGO WILL PROVIDE A FOLLOW-UP REPORT(S) ONCE RELEVANT INFORMATION HAS BECOME AVAILABLE.

    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. STAGO INVESTIGATED THE EVENT UNDER CORPORATE COMPLAINT FILE (B)(4). (B)(6)2018: ADDITIONAL VERBAL COMMUNICATION RECEIVED FROM THE CUSTOMER INDICATED THAT NONE OF THE PATIENTS MENTIONED IN THIS INCIDENT HAD ANY FURTHER COMPLICATIONS. THE CUSTOMER ALSO STATED THEY SWITCHED TO USING APTT FOR MONITORING AND THE PATIENTS WERE STABILIZED. NO FURTHER PATIENT INFORMATION HAS BEEN RECEIVED. (B)(6)2018: THE SYSTEM DUMP FILE WAS ANALYZED, BUT IT WAS NOT POSSIBLE TO OBTAIN THE PATIENTS' TUBES IDENTIFICATION. THE KINETICS OF THE CURVES ANALYZED APPEAR NORMAL AND NO ERRORS WERE OBSERVED. THE NEEDLE WAS REPLACED AS PER CUSTOMER'S REQUEST DUE TO 100K CYCLES BEING REACHED AND THE SOFTWARE WAS PROMPTING FOR ITS REPLACEMENT. THE CUSTOMER NEVER ANSWERED STAGO'S ADDITIONAL QUESTIONS, DESPITE SEVERAL DOCUMENTED REQUESTS. THIS CASE IS ISOLATED AND THIS COMPLAINT IS UNVERIFIABLE. THE DATA OBTAINED DOES NOT ALLOW FOR AN INVESTIGATION OF THE COMPLAINT THAT WOULD INDICATE THAT THERE WAS A TRUE MALFUNCTION OF THE DEVICE. STAGO IS CONCLUDING ITS INVESTIGATION INTO THIS MATTER.

    Description of Event or Problem · 0

    ON (B)(6) 2018: STAGO HOTLINE RECEIVED A CALL FROM THE CUSTOMER INDICATING THAT THERE WERE SOME SAMPLES THAT RESULTED AS <MIN FOR ANTIXA. THE SAMPLES WERE REPEATED AND RESULTED AS <MIN. FOUR PATIENTS WERE DOSED BASED UPON THE <MIN AND EACH PATIENT HAD A BLEEDING EVENT. STAGO WAS NOT ABLE TO CONFIRM ANY ADVERSE EVENT UNTIL THE CUSTOMER SENT THE QUESTIONNAIRE ON (B)(6) 2018. IT WAS DOCUMENTED IN THE QUESTIONNAIRE THAT THE TREATMENTS DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, NOR DID THEY NECESSITATE MEDICAL OR SURGICAL INTERVENTION. ON (B)(6) 2018: A STAGO FIELD SUPPORT ENGINEER (FSE) ARRIVED AT THE CUSTOMER SITE TO EVALUATE THE SYSTEM. THE FSE REPLACED THE CAP-PIERCING NEEDLE - A USER REPLACEABLE ITEM - FROM THE CUSTOMER'S STOCK. INSTRUMENT PERFORMANCE WAS VERIFIED BY THE FSE AND WAS DEEMED TO BE PERFORMING WITHIN STAGO SPECIFICATIONS. ON (B)(6) 20108: THE CASE ((B)(4)) WAS SENT TO STAGO HQ (MANUFACTURER) FOR THEIR REVIEW AND INVESTIGATION WHICH IS CURRENTLY ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601001 STA-R EVOLUTION EVOLUTION JPA DIAGNOSTICA STAGO S.A.S. IVD COAGULATION DEVICE/INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other