BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STA-R EVOLUTION

    MDR report key: 8455816 · Received March 27, 2019

    Report

    Report Number
    8043273-2019-00004
    Event Type
    Malfunction
    Date Received
    March 27, 2019
    Date of Event
    February 28, 2019
    Report Date
    February 28, 2019
    Manufacturer
    DIAGNOSTICA STAGO S.A.S.
    Product Code
    JPA
    PMA / PMN Number
    K082675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 20MAR2019: THE MANUFACTURER GAVE THEIR CONCLUSION TO THE INVESTIGATION. THE DIAGNOSTICA STAGO FIELD SUPPORT ENGINEER NOTICED THAT NEEDLE #1 WAS BENT AND HITTING THE EDGE OF THE TUBE/VIAL, DISRUPTING SAMPLING. DUE TO CONTAMINATION THE PARTS REPLACED (NEEDLE #1 AND WASHING WELL #3) WERE DISCARDED BUT PICTURES WERE PROVIDED. QC WAS IN BEFORE AND AFTER THE SAMPLE RUN. THERE WAS NO SPECIFIC WARNING TO THE CUSTOMER AND RESULTS WERE RELEASED. THE MOST LIKELY ROOT CAUSE WAS A COMBINATION OF FAILED NEEDLE #1 AND WASHING WELL #3. SINCE THE PARTS WERE DISCARDED DUE TO CONTAMINATION, IT IS NOT POSSIBLE TO INVESTIGATE ANY FURTHER. THE MANUFACTURER HAS CONCLUDED THEIR INVESTIGATION INTO THIS MATTER.

    Description of Event or Problem · 0

    ON (B)(6) 2019: THE DIAGNOSTICA STAGO INC. HOTLINE RECEIVED A CALL FROM THE MEDICAL COLLEGE OF (B)(6) COAG LAB STATING THAT ERRONEOUS RESULTS WERE PRODUCED AND RELEASED. THE RESULTS WERE QUESTIONED BY THE NURSING STAFF AND RERUN ON THEIR OTHER INSTRUMENT. IT PRODUCED RESULTS MATCHING THE PREVIOUS ONES. ON (B)(6) 2019: THE CUSTOMER REPORTED THAT THE ERRONEOUS RESULTS FAILED DELTA CHECKS BUT WERE RELEASED. THE AFFECTED TESTS WERE FOR PT, PTT, D-DIMER, AND FIBRINOGEN. THE CUSTOMER ALSO STATED THAT THE TESTS WERE NOT RERUN AS PREVIOUSLY STATED AND WERE ACCEPTED KNOWING THAT THE DELTA CHECKS HAD FAILED. ON (B)(6) 2019: THE CUSTOMER PROVIDED INFORMATION ON THE STAGO QUESTIONNAIRE. A TOTAL OF FIVE PATIENT RESULTS WERE AFFECTED AND THERE WAS NO HARM OR INJURY TO ANY OF THE PATIENTS. THE MANUFACTURER WAS NOTIFIED BY EMAIL ABOUT A POTENTIAL REPORTABLE EVENT. THIS INCIDENT IS CONSIDERED A MALFUNCTION SINCE QC WAS IN RANGE BEFORE AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249880 STA-R EVOLUTION IVD COAGULATION DEVICE/INSTRUMENT JPA DIAGNOSTICA STAGO S.A.S. 58978

    Patients

    Seq Age Sex Outcome Treatment
    1