BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STA COMPACT MAX

    MDR report key: 7735696 · Received July 31, 2018

    Report

    Report Number
    8043723-2018-00001
    Event Type
    Injury
    Date Received
    July 31, 2018
    Date of Event
    June 19, 2018
    Report Date
    June 19, 2018
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K130090
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DIAGNOSTICA STAGO, INC. IS SUBMITTING THIS REPORT ON BEHALF OF DIAGNOSTICA STAGO S..A.S. (B)(4) (MANUFACTURER) UNDER EXEMPTION NUMBER E2012018. STAGO INVESTIGATED THE EVENT UNDER CORPORATE COMPLAINT FILE (B)(4). THE OPERATOR OF THE INSTRUMENT DOES NOT RECALL THE SEQUENCE OF REMOVING THE CUVETTES(E.G. AUTOMATIC THEN FOLLOWED BY A MANUAL). THE FILES RETRIEVED BY THE STAGO FIELD SUPPORT ENGINEER DID NOT CONTAIN INFORMATION FROM THE DAY OF THE INCIDENT. THEREFORE, A TRUE ROOT CAUSE CANNOT BE DETERMINED, NOR CAN INSTRUMENT MALFUNCTION BE CONFIRMED. STAGO IS CONCLUDING ITS INVESTIGATION INTO THIS MATTER. NOTE: NUMEROUS ATTEMPTS WERE MADE TO SUBMIT THIS MDR (01OCT2018, 02OCT2018, 16OCT2018, AND 17OCT2018) AND NUMEROUS TICKETS WERE OPENED. THE LAST WAS (B)(4).

    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. A STAGO FIELD SUPPORT ENGINEER WAS DISPATCHED TO INVESTIGATE THE ISSUE. WHILE AT THE CUSTOMER SITE HE "CLEANED THE CUVETTE SUCTION TIP AND HEAD. CHECKED SAFETY FEATURES IN MULTIPLE SITUATIONS, EVERY SITUATION TESTED WORKED AS SPECIFIED. COULDN'T DUPLICATE THE ISSUE REPORTED." SYSTEM TESTING: PASSED ENDURANCE AND QC. (B)(6) SIGNED THE WORK ORDER CONTAINING THE WORK PERFORMED BY THE FSE STATED ABOVE. INVESTIGATIONS ARE CURRENTLY IN PROGRESS. THE CONCLUSION WILL BE COMMUNICATED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018, (B)(6) CONTACTED THE STAGO HOTLINE TO REPORT "THAT ONE OF HIS TECHS, ... WAS HURT WHILE WORKING ON THE STAGO INSTRUMENT. SHE WAS TRYING TO RETRIEVE A BROKEN CUVETTE OUT OF THE INSTRUMENT. (B)(6) SAYS THAT HIS TECH STATED THAT THE SAMPLE ARM MOVED SUDDENLY AND BRUISED AND SCRATCHED HER ARM. SHE WAS PLACED ON ANTIBIOTICS. AN INCIDENT REPORT WAS REQUESTED BY STAGO BUT WAS NOT SUPPLIED BY THE CUSTOMER. A STAGO FIELD SUPPORT ENGINEER WAS DISPATCHED TO INVESTIGATE THE ISSUE. WHILE AT THE CUSTOMER SITE HE "CLEANED THE CUVETTE SUCTION TIP AND HEAD. CHECKED SAFETY FEATURES IN MULTIPLE SITUATIONS, EVERY SITUATION TESTED WORKED AS SPECIFIED. COULDN'T DUPLICATE THE ISSUE REPORTED." SYSTEM TESTING: PASSED ENDURANCE AND QC. (B)(6) SIGNED THE WORK ORDER CONTAINING THE WORK PERFORMED BY THE FSE STATED ABOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576239 STA COMPACT MAX COMPACT MAX JPA DIAGNOSTICA STAGO S.A.S. IVD COAGULATION DEVICE/INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other