BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA COMPACT MAX

    MDR report key: 13073476 · Received December 23, 2021

    Report

    Report Number
    8043723-2021-00001
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    November 30, 2021
    Report Date
    June 26, 2025
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    UDI-DI
    03607450589894
    PMA / PMN Number
    K130090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, A SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER FOR EVALUATION/REPAIR. SEVERAL ACTIONS WERE DONE : VACUUM ADJUSTMENT, AND A CHANGE OF SYRINGE, WASHWELL, AND TUBE Z3. THE FSE ALSO FOUND CUVETTE BALLS LYING AROUND. ON (B)(6) 2021, THE FSE WAS DISPATCHED AGAIN; THE FSE CHANGED THE CAP PIERCING NEEDLE, THE PINCH VALVE, THE PIERCING MECHANISM, AND THE BLOCK OF 3 ELECTROVALVES. THE INSTRUMENT DATA FILES HAVE BEEN COLLECTED AND THE ANALYSIS IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE. THE STAGO REFERENCE COMPLAINT IS (B)(4).

    Additional Manufacturer Narrative · 0

    THE INSTRUMENT DATA FILES WERE ANALYZED BY OUR R&D DEPARTMENT. THEY HAVE CHECKED THE PIPETTING HEIGHTS ON THE CONCERNED PATIENT'S SAMPLE TUBE (WITH ERRONEOUS RESULTS RELEASED) AND CONFIRMED THAT THE LEVEL DETECTIONS OCCURRED TOO HIGH, BEFORE REACHING THE TUBE (JUST ABOVE THE CAP). THESE LEVEL DETECTION RESULTED IN PIPETTING IN THE AIR WHICH IS CONSISTENT WITH THE WRONG <0.1 UI/ML RESULTS. THE FIELD SUPPORT ENGINEER'S INTERVENTIONS ON 8 AND 10 DECEMBER 2021 RESULTED IN THE CHANGING OF SEVERAL SPARE PARTS, HOWEVER THERE IS NO EVIDENT RELATIONSHIP BETWEEN THIS RANDOM ISSUE AND THE SPARE PARTS CHANGED. CONCLUSION: THE INSTRUMENT FILE ANALYSIS AND LOCAL INTERVENTION DID NOT LEAD TO A CONCLUSIVE DETERMINATION OF THE ROOT CAUSE OF THIS RANDOM AND RARE LEVEL DETECTION ERROR. STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS MATTER AND CONSIDERS IT AS CONFIRMED AND ISOLATED, AND PLANS NO FURTHER ACTION IN THIS MATTER. STAGO REFERENCE : (B)(4). SUPPLEMENTAL REQUESTED BY FDA _(B)(4).

    Description of Event or Problem · 0

    FOUR ERRONEOUS UFH RESULTS WITH STA LIQUID ANTI-XA REAGENT ON STA COMPACT MAX ANALYZER WERE REPORTED. ALL OF THEM WERE FALSELY <0.1 IU / ML RESULTS (ABSENCE OF HEPARIN). ON (B)(6) 2021 : RESULTS <0.1 IU / ML. THEN, TESTS RERAN THE SAME DAY ON ANOTHER INSTRUMENT: PATIENT 1: RELEASED AT 0.51 IU / ML. PATIENT 2: RELEASED AT 1.11 IU / ML. PATIENTS 1 & 2 HAVE RECEIVED A CHANGE IN THE THERAPY BUT NO SERIOUS INJURY WAS REPORTED. ON (B)(6) 2021: RESULTS <0.1 IU / ML. THEN, TESTS RERAN 30MIN LATER ON THE SAME INSTRUMENT: PATIENT 3: RELEASED AT 0.33 IU / ML. PATIENT 4: RELEASED AT 0.21 IU / ML. NO INFORMATION ABOUT ANY CHANGES IN TREATMENT FOR THESE PATIENTS. NO SERIOUS INJURY TO OUR KNOWLEDGE. THE INTERNAL QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES BEFORE AND AFTER THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1980716 STA COMPACT MAX IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S. 58989 03607450589894

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown