BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA COMPACT MAX

    MDR report key: 8263851 · Received January 21, 2019

    Report

    Report Number
    8043273-2019-00001
    Event Type
    Injury
    Date Received
    January 21, 2019
    Date of Event
    November 3, 2018
    Report Date
    April 12, 2019
    Manufacturer
    DIAGNOSTICA STAGO S.A.S
    Product Code
    JPA
    PMA / PMN Number
    K130090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATIONS / IDENTIFICATION OF CAUSES: THE INSTRUMENT DATA WAS ANALYZED: QUALITY CONTROLS BEFORE THE ERRONEOUS RESULTS WERE WITHIN RANGE. QUALITY CONTROLS AFTER THE ERRONEOUS RESULTS WERE SLIGHTLY OUT OF RANGE. THE CURVE OF THE ERRONEOUS RESULTS WERE CORRECT, WITHOUT ANY DISTURBANCES. THE ANALYSIS OF THE LEVEL OF SAMPLING IN THE INCRIMINATED TUBE SHOWS A SAMPLING PROBLEM FOR THE FIRST AND SECOND MEASUREMENTS: THE PLASMA WAS DETECTED AS BEING HIGHER THAN ON THE CORRECT MEASUREMENT (THE THIRD). THE MOST PROBABLE ROOT CAUSE EXPLAINING THE WRONG SAMPLING LEVELS IS THE PRESENCE OF A BUBBLE ON THE SURFACE OF THE PLASMA. THE REFERENCE MANUAL OF THE INSTRUMENT INDICATES THAT THE CUSTOMERS SHOULD BE CAREFUL ABOUT THE PRESENCE OF BUBBLES IN THE TUBES BECAUSE BUBBLES COULD LEAD TO INCORRECT RESULTS. NOTE: THE INSTRUMENT DID WARN THE CUSTOMER ABOUT THE FILLING OF THE TUBE. AN ALARM WAS FOUND IN THE PATIENT FILE. THE FILLING OF THE TUBE WAS OUT OF THE ACCEPTABLE RANGE. CORRECTIVE ACTIONS PROPOSED / CARRIED OUT FOLLOWING THE ANALYSIS OF THE CAUSES: NO CORRECTIVE ACTION WILL BE PUT IN PLACE FOR THIS CASE BASED ON THE ISOLATED EVENT. STAGO HAS CONCLUDED ITS INVESTIGATION INTO THIS EVENT.

    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. THE EVENT OCCURRED IN FRANCE BUT THE DEVICE IS ALSO MARKETED IN THE USA. THE HOTLINE (STAGO'S PHONE TECHNICAL SUPPORT) WAS ABLE TO DO A REMOTE ANALYSIS OF THE INSTRUMENT AND DID NOT FIND ANY SYSTEM PERFORMANCE ISSUES. NO OTHER PATIENTS WERE IMPACTED. THE PATIENT WAS HOSPITALIZED BUT DID NOT SUFFER ANY LONG-TERM EFFECTS. NO ADDITIONAL INFORMATION REGARDING THE PATIENT'S CONDITION IS KNOWN AT THIS TIME. SYSTEM DUMP FILES ARE BEING REVIEWED AND THE INVESTIGATION IS CONTINUING UNDER FILE # (B)(4). STAGO WILL PROVIDE A FOLLOW-UP REPORT(S) ONCE RELEVANT INFORMATION HAS BECOME AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 9:29AM: INCONSISTENT RESULTS FOR PT=54.1 SEC AND INR=12.52 WERE PRODUCED FOR A SINGLE PATIENT SAMPLE. ON (B)(6) 2018 9:45AM: THE SAMPLE WAS RE-TESTED AND PRODUCED RESULTS OF PT=42.5 SEC AND INR=8.19. ON (B)(6) 2018 2:55PM: IT WAS RE-RESTED AGAIN AND PRODUCED RESULTS OF PT=24.4SEC AND INR=3.40. THE RELEASED RESULT WAS AN AVERAGE OF THE FIRST TWO RESULTS. THE INR WAS REPORTED AS 10.36. THE PATIENT TREATMENT WAS INAPPROPRIATELY MODIFIED. (VITAMIN K WAS ADMINISTERED). THE CORRECTED RESULT WAS LATER RELEASED (INR=3.40) AT 2:55PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58454 STA COMPACT MAX IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization