BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STA-R EVOLUTION

    MDR report key: 6621426 · Received June 8, 2017

    Report

    Report Number
    8043723-2017-00001
    Event Type
    Malfunction
    Date Received
    June 8, 2017
    Date of Event
    February 23, 2017
    Report Date
    February 24, 2017
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    UDI-DI
    03607450589788
    PMA / PMN Number
    K082675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2017, THE ACCOUNT CALLED THE DIAGNOSTICA STAGO HOTLINE TO REPORT THREE ERRONEOUS RESULTS. AMONG THESE THREE RESULTS, ONLY THE TWO FOLLOWING HAVE BEEN DETAILED: SAMPLE 1 ((B)(6) 2017): ORIGINAL RESULTS: PT = 31.6 SEC WITH INR = 3.11; REPEATED: PT = 12.9 SEC WITH INR = 1.1. SAMPLE 2 ((B)(6) 2017): ORIGINAL RESULTS: APTT = 37.6 SEC; REPEATED: APTT = 26.8 SEC. THE CUSTOMER QUESTIONED THE RESULTS AND RERAN THE SAMPLES ON ANOTHER STAGO INSTRUMENT. THE RESULTS WERE THEN AS THE CUSTOMER EXPECTED. THE QUALITY CONTROL (QC) RESULTS BEFORE AND AFTER THE ERRONEOUS RESULTS WERE FOUND WITHIN THE DEFINED RANGE. ON (B)(6) 2017 THE ACCOUNT CLARIFIED TO THE HOTLINE THAT THE TWO CONCERNED PATIENTS HAD THEIR REPORTS AMENDED. THE ACCOUNT STATED IN WRITING THAT PATIENTS WERE NOT TREATED AND THEREFORE UNINJURED. THE SAME DAY, THE FSE ARRIVED ON SITE AND NOTICED THAT THE NEEDLE WAS SOMETIMES HITTING THE TUBE CAPS. UPON CHECKING THE MAPPING, ARM #1 STOPPED WORKING. TO RESOLVE THE ISSUE, THE FSE REPLACED THE X, Y, AND Z MOTORS, BOTH ARM CIRCUIT BOARDS, AND THE MAIN RACK MULTIFUNCTION CIRCUIT BOARD. THE SYSTEM WAS RESTORED TO STAGO SPECIFICATIONS THAT DAY. IT IS IMPORTANT TO NOTE THAT THE ENGINEER MEASURED SOME POWER DEFICIENCIES WITH THE OUTLET TO WHICH THE ANALYZER WAS ATTACHED, AND CONNECTED THE ANALYZER TO A DIFFERENT OUTLET. AS PER PROCEDURE, CERTAIN REPLACED PARTS WERE RETURNED TO STAGO HEADQUARTERS FOR EVALUATION. ALTHOUGH A TRUE ROOT CAUSE COULD NOT BE DETERMINED BY DIAGNOSTICA STAGO (B)(4) (MANUFACTURER), TWO HYPOTHESIS HAVE BEEN MADE: POWER FLUCTUATIONS AT THE CUSTOMER'S SITE HAVE MADE ONE OF THE ARM CIRCUIT BOARDS (PCB 4 AXIS) DEFICIENT. ARM 1 HIT RANDOMLY THE TUBE CAPS DUE TO INCORRECT SYSTEM MAPPING. IN BOTH CASES, IT WAS A LOCAL AND TEMPORARY ISSUE. AS OF TODAY, DIAGNOSTICA STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403152 STA-R EVOLUTION EVOLUTION JPA DIAGNOSTICA STAGO S.A.S. IVD COAGULATION DEVICE/INSTRUMENT NA 03607450589788

    Patients

    Seq Age Sex Outcome Treatment
    1