BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STA R MAX

    MDR report key: 8731163 · Received June 25, 2019

    Report

    Report Number
    8043723-2019-00006
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    May 20, 2019
    Report Date
    October 10, 2019
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K151867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT SHOULD BE NOTED THAT REGARDING THE INFORMATION, INVESTIGATIONS ARE MOVING TOWARDS AN INSTRUMENTATION ISSUE RATHER THAN A REAGENT ISSUE. INDEED, IN THE CASE OF A REAGENT ISSUE, THE PROBLEM WOULD BE SYSTEMATIC, WITH A LIKELY IMPACT ON QUALITY CONTROLS, AND WE WOULD CERTAINLY HAVE RECEIVED MATCHING CALLS. THE CLIENT CONFIRMED THAT THERE WERE NO CONSEQUENCES FOR THE HEALTH OF THE TWO PATIENTS CONCERNED. A CHECK OF THE PRE-ANALYTICAL ELEMENTS WAS CARRIED OUT WITH THE CLIENT AND DID NOT REVEAL ANY NON-CONFORMITY. WE INVESTIGATED THE DUMP: NO SAMPLING PROBLEM (LEVEL DETECTION HEIGHTS WERE COMPLIANT) KINETICS WERE NORMAL IN TCK. WE CAN RULE OUT A SAMPLING PROBLEM OF INTERMEDIATE AND TRIGGERING REAGENTS (THIS CAN NOT CAUSE A SHORTENING OF THE TIMES ON A HAEMOPHILIAC SAMPLE). NO INVESTIGATION WAS POSSIBLE ON THE OTHER PATIENT DUE TO A LACK OF DATA TO IDENTIFY HIM IN THE DUMP. THE VARIOUS INTERVENTIONS CARRIED OUT ON THE CUSTOMER SITE DO NOT HELP US TO IDENTIFY THE ORIGIN OF THE PROBLEM RAISED. CONCLUSION: THE ORIGIN OF THE ERRONEOUS RESULT ON THE HAEMOPHILIAC PATIENT IS NOT ESTABLISHED. THE SECOND CASE IS UNVERIFIABLE DUE TO LACK OF DATA. NO CORRECTIVE ACTION WILL BE IMPLEMENTED WITHIN THE FRAMEWORK OF THIS FILE BASED ON THE INVESTIGATIONS CARRIED OUT. ON 2019/09/30, IT SHOULD BE NOTED THAT WE NO LONGER HAVE SIMILAR REPORT FROM THE CUSTOMER SITE. THIS CASE IS CONSIDERED AS ISOLATED AND CLOSED.

    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. ADDITIONAL ELEMENTS ARE BEING RECOVERED FROM THE CUSTOMER: INFORMATION ON THE ERRONEOUS RESULTS. INSTRUMENTATION DATA (DUMP) FOR ANALYSIS. WHILE WAITING FOR THE RECOVERY OF THESE ELEMENTS, THE FIRST CAUSE ANALYSIS CAN NOT BE YET REALIZED. FOR THE SAME REASON, IT IS TOO EARLY TO DEFINE ANY CORRECTIVE ACTIONS. IT SHOULD BE NOTED, HOWEVER, THAT REGARDING THE INFORMATION AVAILABLE AT THIS STAGE, INVESTIGATIONS ARE MOVING TOWARDS AN INSTRUMENTATION ISSUE RATHER THAN A REAGENT ISSUE. INDEED, IN THE CASE OF A REAGENT ISSUE, THE PROBLEM WOULD BE SYSTEMATIC, WITH A LIKELY IMPACT ON QUALITY CONTROLS, AND WE WOULD CERTAINLY HAVE RECEIVED SIMILAR CALLS / CASE. THE FOLLOWING IMMEDIATE ACTIONS WERE CARRIED OUT ON (B)(6) 2019: INTERVENTION ON THE CONCERNED INSTRUMENT, VERIFICATION OF PRE-ANALYTICAL ELEMENTS WITH THE CLIENT. (B)(4).

    Description of Event or Problem · 0

    DURING THE SAME WEEK, TWO DISCREPANCIES IN RESULTS WERE OBSERVED: DISCREPANCY BETWEEN A FACTOR VIII RESULT IN A KNOWN HEMOPHILIAC PATIENT (FVIII = 3%) AND THE RESULT OF TCK RATIO = 1.23 (NORMAL FOR AGE). RELAUNCH OF TCK RATIO = 2.04. DISCREPANCY BETWEEN THE RESULTS OF TCK RATIO = 1 AND PT = 27% WITH REDUCED FACTOR II AND FACTOR V. RELAUNCH OF TCK RATIO = 1.26 (CHECKED TWICE). INTERNAL QUALITY CONTROLS ARE WITHIN ACCEPTABLE RANGES. AT THIS TIME, THERE IS NO HEALTH IMPACT REPORTED FOR THESE TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524340 STA R MAX IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S. 58992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other