BEUDAMED
    FDA Adverse Event Death Summary report: N

    APTIO AUTOMATION

    MDR report key: 9529546 · Received December 30, 2019

    Report

    Report Number
    3010825766-2019-00014
    Event Type
    Death
    Date Received
    December 30, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 30, 2019
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOG FILES ANALYSIS PERFORMED BY THE PRODUCT DISTRIBUTOR SHOWS THAT THE SAMPLE TUBE INVOLVED IN THE INCIDENT HAS BEEN UPLOADED ON THE AUTOMATION SYSTEM AT THE 4:34:14 PM OF (B)(6) 2019. THE SAMPLE TUBE HAS BEEN CORRECTLY PROCESSED AT THE ANALYZER AND AT THE END OF THE TESTS, IT HAS BEEN SEALED AND AT 4:58:59 PM IT WAS ROUTED TO THE STORAGE AND RETRIEVAL MODULE (SRM) IN ORDER TO BE KEPT IN CONTROLLED CONDITIONS. AT 5:57:49 PM THE SAMPLE TUBE WAS RETRIEVED FROM THE SRM DUE TO AN ADDITIONAL ORDER RECEIVED FROM LABORATORY INFORMATION SYSTEM (LIS): THE TUBE WAS PROCESSED AS INTENDED AND AT 6:10:58 PM IT WAS PLACED AGAIN ON THE SRM AFTER BEING SEALED. THE SAME OCCURRED AT 6:41:48 PM AND AT 6:50:41 PM IT WAS PLACED BACK IN THE SRM AFTER BEING SEALED. THE ANALYSIS SHOWS THAT AN ADDITIONAL ORDER WAS RECEIVED BY LIS AND AT 7:36:43 PM THE SAMPLE TUBE WAS RETRIEVED FROM SRM FOR THE THIRD TIME: WHEN THE TUBE WAS DIVERTED TO THE DESEALER MODULE (DSM) AT 7:38:52 PM (BEFORE BEING ROUTED TO THE ANALYZER), THE AUTOMATION SYSTEM GENERATED AN ERROR MESSAGE SC021 "SAMPLE NEEDS MANUAL UNSEAL - TUBE SEALED TOO MANY TIMES". A SAMPLE TUBE IS FLAGGED WITH THIS ERROR WHEN IT CANNOT BE AUTOMATICALLY DESEALED BECAUSE THE CONFIGURED DESEALER MAXIMUM NUMBER OF SEALS WAS EXCEEDED. THE ERROR RECOVERY FORESEES THAT THE IMPACTED TUBE IS SENT TO A SPECIFIC RACK LOCATED IN THE PRIORITY OUTPUT (PO) IN ORDER TO BE VISUALLY INSPECTED AND MANUALLY MANAGED BY THE LABORATORY TECHNICIAN. THE ANALYSIS SHOWS THAT AT 7:39:30 PM THE SAMPLE TUBE WAS IN THE RACK WAITING FOR OPERATOR INTERVENTION, BUT IT WAS NOT INTRODUCED BACK ON TO THE AUTOMATION SYSTEM UNTIL 9:25:32 PM. INPECO AUTOMATION SYSTEM BEHAVED ACCORDING TO SPECIFICATIONS AND THERE WAS NO NEED FOR SERVICE OR MAINTENANCE. THE INSTRUCTIONS FOR THE ERROR RECOVERY ARE CONSIDERED ADEQUATE, SO NO DESIGN CHANGE IS FORESEEN: NO FIELD SAFETY CORRECTIVE ACTION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE PRODUCT DISTRIBUTOR NOTIFIED INPECO THAT ON (B)(6) 2019 A PATIENT ARRIVED AT THE EMERGENCY ROOM (ER) OF THE HOSPITAL AND EXPIRED. THE PATIENT HAD A TUBE CLASSIFIED AS PRIORITY (STAT) WITH A TEST ORDER FOR TROPONIN (TNIH), THE CUSTOMER REPORTED A DELAY FOR THE TROPONIN RESULT OF MORE THAN 1 HOUR. THE EMERGENCY ROOM NURSE FOLLOWED UP ON THE TROPONIN RESULTS MULTIPLE TIMES, MAKING THE LABORATORY OPERATOR AWARE OF THE DELAY. THE CUSTOMER DID NOT PROVIDE THE CAUSE OF THE PATIENT EXPIRING, NOR THE MEDICATIONS THAT WERE BEING TAKEN AT THE TIME OF THE EVENT. NO INFORMATION WAS PROVIDED ABOUT THE POSSIBILITY THAT A MEDICAL PROCEDURE WAS PERFORMED, DELAYED OR WITHHELD DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1326396 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death