BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STA-R EVOLUTION

    MDR report key: 8435968 · Received March 20, 2019

    Report

    Report Number
    8043273-2019-00003
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    February 20, 2019
    Report Date
    February 20, 2019
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K082675
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE SUMMARY OF THE INVESTIGATION CARRIED OUT FOR CORPORATE COMPLAINT (B)(4). INVESTIGATIONS / IDENTIFICATION OF CAUSES: THE ANALYSIS OF THE INTERNAL INSTRUMENT FILES SHOWS THAT THE KINETICS ASSOCIATED WITH THE ERRONEOUS RESULTS ARE NOT DISTURBED. ALL THE RESULTS RETURNED ARE PROLONGED (EVEN IN M> MMAX) COMPARED TO THE CORRECTED RESULTS. THIS IS COMPATIBLE WITH THE MOST PROBABLE ROOT CAUSE OF A PROBLEM OF SAMPLING RELATED TO A LEAK. IN THE INTERNAL INSTRUMENT FILES, THE FOLLOWING EVENTS WERE CAPTURED: ON THE MORNING OF THE INCIDENT AT 7:18 AM, THE CUSTOMER PERFORMED THE INSTRUMENT MAINTENANCE INCLUDING THE REPLACEMENT OF SYRINGE #1 AND THE TEFLON TIPS. QC FOR PT, APTT, FIB WERE IN THE RANGE AT 8:20 AM AND 11:30 AM AND THEREFORE DID NOT DETECT ANY ANOMALY. THE AFFECTED PATIENT SAMPLES WERE RUN BETWEEN 1:30 PM AND 2:00 PM. AT 2:25 PM THERE WAS A PROBLEM OF GRIPPING RESULTING IN THE LOSS OF A CUVETTE IN THE INSTRUMENT. IT WAS ON THIS OCCASION THAT THE CLIENT NOTICED THE LEAK AND IDENTIFIED THE PROBLEM OF SYRINGE #1 NOT BEING SUFFICIENTLY TIGHTENED. QC FOR PT, APTT, FIB WERE WITHIN THE ACCEPTABLE RANGE AT 3 PM, BUT AT THIS POINT IT IS LIKELY THAT THE SYRINGE WAS ALREADY TIGHTENED BY THE CLIENT. THERE ARE SOME OTHER M>MMAX RESULTS, BUT MOST OF THE OTHER SAMPLES RESULTED WITHOUT ISSUE THE SAME DAY. THIS SUGGESTS THAT THE SAMPLING PROBLEM CAUSED BY THE LEAK WAS NOT SYSTEMATIC, HENCE THE LACK OF DETECTION BY QC. CORRECTIVE ACTIONS PROPOSED / CARRIED OUT FOLLOWING THE ANALYSIS OF THE CAUSES: NO CORRECTIVE ACTION WILL BE TAKEN FOLLOWING THE ANALYSIS OF THIS CLAIM, SINCE IT IS AN ISOLATED USER MAINTENANCE ERROR (SYRINGE # 1 NOT PROPERLY TIGHTENED). STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS MATTER.

    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. INVESTIGATIONS ARE STILL ON GOING UNDER CORPORATE COMPLAINT RC-19-0020. STAGO WILL PROVIDE A FOLLOW-UP REPORT(S) ONCE RELEVANT INFORMATION HAS BECOME AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2019: THE DIAGNOSTICA STAGO INC. HOTLINE RECEIVED A CALL FROM THE MEDICAL COLLEGE OF VIRGINIA COAG LAB STATING THEY HAD AN EARLIER ISSUE WITH A LEAKING NEEDLE #1 THAT WAS DISCOVERED DURING A CUVETTE JAM. DURING THIS TIME, ERRONEOUS RESULTS WERE PRODUCED AND RELEASED. THE ACCOUNT REPORTED THAT ALL RESULTS WERE CORRECTED AND THE PHYSICIANS NOTIFIED, BUT TWO PATIENTS WERE TREATED BASED ON THE RESULTS. ONE WAS TRANSFUSED BLOOD PRODUCTS (1 UNIT OF CRYOPRECIPITATE) AND ANOTHER HAD A PROCEDURE DELAYED. THE PROCEDURE WAS DETERMINED TO BE A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). ON (B)(6) 2019: A DIAGNOSTICA STAGO INC. FIELD SUPPORT ENGINEER (FSE) ARRIVED AT THE CUSTOMER FACILITY. THE CUSTOMER HAD ALREADY ADDRESSED THE ISSUE OF THE LEAKING NEEDLE BY TIGHTENING THE FITTING. THE FSE NOTED THAT THE QC WAS IN WITHOUT ANY APPARENT SHIFTS. THE CUSTOMER DID MENTION TO THE FSE THAT THERE WERE SOME CORRELATION ISSUES FOR PTT BETWEEN THEIR TWO INSTRUMENTS. THE FSE DISCOVERED SOME CARRYOVER ON THE INSTRUMENT IN QUESTION. ALL NEEDLES AND SYRINGES WERE REPLACED. ANOTHER CARRYOVER AND PRECISION TEST WAS PERFORMED AND THE INSTRUMENT WAS WORKING WITHIN STAGO SPECIFICATIONS. ON (B)(6) 2019: ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER REGARDING THE PATIENTS' CONDITIONS. IT WAS WELL DOCUMENTED BY THE DIRECTOR OF HEMOSTASIS THAT THE RESULTS FOR BOTH PATIENTS "WERE NOT LIFE THREATENING, THEY DID NOT RESULT IN SERIOUS INJURY, BODILY IMPAIRMENT, PERMANENT DAMAGE, OR DEATH". THE ONE PATIENT WAS "INCONVENIENCED WITH HAVING THE PROCEDURE PERFORMED THE FOLLOWING DAY". THE OTHER WAS "INCONVENIENCED WITH HAVING TO RECEIVE A BLOOD PRODUCT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228875 STA-R EVOLUTION IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S. 58978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other