BEUDAMED
    FDA Adverse Event Death Summary report: N

    APTIO AUTOMATION

    MDR report key: 9505082 · Received December 20, 2019

    Report

    Report Number
    3007494875-2019-00002
    Event Type
    Death
    Date Received
    December 20, 2019
    Date of Event
    December 2, 2019
    Report Date
    January 16, 2020
    Manufacturer
    INPECO S.P.A
    Product Code
    LXG
    UDI-DI
    07640172342008
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    THE INITIAL MDR 3007494875-2019-00002 WAS FILED ON 20-DEC-2019. ADDITIONAL INFORMATION (30-DEC-2019): THE MANUFACTURER OF THE DEVICE SUBMITTED MDR 3010825766-2019-00014 ON 30-DEC-2019.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THERE WAS A DELAY IN OBTAINING A TROPONIN (TNIH) TEST RESULT FOR A PATIENT SAMPLE FOR APPROXIMATELY AN HOUR ON (B)(6) 2019. THE CUSTOMER REPORTED THAT THE PATIENT EXPIRED WHILE AWAITING THE TROPONIN (TNIH) RESULT. THE EMERGENCY ROOM NURSE FOLLOWED UP ON THE TROPONIN RESULTS MULTIPLE TIMES, MAKING THE OPERATOR AWARE OF THE DELAY. STATEMENTS AND ACTIONS ATTRIBUTED TO THE CUSTOMER ARE DERIVED FROM INFORMATION SUBMITTED TO THE SIEMENS COMPLAINT HANDLING SYSTEM AND HAVEN'T BEEN VERIFIED. SIEMENS INVESTIGATED THE INSTRUMENT FILES AND DETERMINED THAT AN INITIAL PANEL OF BLOOD TESTS WERE ORDERED ON THE PATIENT SAMPLE. A TROPONIN TEST WAS SUBSEQUENTLY ORDERED ON THE PATIENT SAMPLE. SIEMENS DETERMINED THAT A SAMPLE TUBE WITH SID (B)(6) WAS RETURNED TO THE APTIO AUTOMATION SYSTEM (SERIAL NUMBER: (B)(4)) ON (B)(6) 2019 AT 4:57:52 PM AFTER BEING PROCESSED ON AN ATELLICA INSTRUMENT FOR THE INITIAL PANEL OF RESULTS. THE TUBE WAS SEALED AND SENT TO STORAGE. AT 6:41:48 PM, THE SAMPLE WAS RETRIEVED FROM STORAGE, DUE TO AN ADD-ON TROPONIN (TNIH) TEST THAT WAS SUBSEQUENTLY ORDERED ON THE SAMPLE AND PROCESSED AT 6:48:55 PM. THEN, THE TUBE WAS SEALED AND SENT TO STORAGE. AT 7:38:43 PM, THE SAMPLE WAS RETRIEVED FROM STORAGE AND AT 7:38:52 PM A DE-SEALER ERROR SC021 "SAMPLE NEEDS MANUAL UNSEAL - TUBE SEALED TOO MANY TIMES" WAS GENERATED BY THE APTIO AUTOMATION SYSTEM, AS INTENDED. THE ERROR CAUSED THE SAMPLE TUBE TO ROUTE TO A PRIORITY OUTPUT LANE FOR OPERATOR INTERVENTION AT 7:39:30 PM, BUT WAS NOT REINTRODUCED ONTO THE TRACK UNTIL 9:25:32 PM. THE DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS, AND THERE WAS NO NEED FOR SERVICE OR MAINTENANCE. SIEMENS IS THE IMPORTER OF THE MEDICAL DEVICE DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295021 APTIO AUTOMATION APTIO AUTOMATION LXG INPECO S.P.A APTIO AUTOMATION 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death