BEUDAMED
    FDA Adverse Event Death Summary report: N

    APTIO AUTOMATION SYSTEM

    MDR report key: 12204318 · Received July 21, 2021

    Report

    Report Number
    3007494875-2021-00001
    Event Type
    Death
    Date Received
    July 21, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 21, 2021
    Manufacturer
    INPECO SA
    Product Code
    LXG
    UDI-DI
    07640172342008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED SIEMENS TO REPORT THAT FLAGGED D-DIMER TEST RESULTS (AN M FLAG SIGNIFYING A RESULT >20) WERE OBTAINED FROM A NON-SIEMENS INSTRUMENT AND WERE TRANSMITTED TO A NON-SIEMENS APTIO AUTOMATION DATA MANAGEMENT SYSTEM (DMS). THE DMS SENT A RESULT OF 0 (ZERO), AND NO M FLAG, TO UPSTREAM MIDDLEWARE AND A LABORATORY INFORMATION SYSTEM (LIS). THE CUSTOMER INDICATED THAT THIS SCENARIO OCCURRED ON THREE PATIENTS WHO LATER EXPIRED. THE LABORATORY'S HEMATOLOGIST STATED THE D-DIMER TEST RESULTS DID NOT CAUSE THE PATIENTS' EXPIRATION. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED. THE LEGAL MANUFACTURER, INPECO SA, FILED MDR 30108257766-2021-00008 WITH THE FDA ON 12-JUL-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101712 APTIO AUTOMATION SYSTEM APTIO AUTOMATION DATA MANAGEMENT SYSTEM LXG INPECO SA APTIO AUTOMATION SYSTEM 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 Death