BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 15690358 · Received October 28, 2022

    Report

    Report Number
    3010825766-2022-00006
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    September 29, 2022
    Report Date
    March 3, 2023
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172342008
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INPECO HAS INVESTIGATED THE EVENT IDENTIFYING A PROBLEM OF SAMPLES ID MISMATCH. IN THE FOLLOWING SCENARIO: THE SRM IS RETRIEVING A SAMPLE TUBE (TUBE A) IN ORDER TO PERFORM ADDITIONAL TEST ORDERS. ANOTHER SAMPLE TUBE (TUBE B) IS ERRONEOUSLY NOT DEVIATED INTO THE SRM PIT LANE DUE TO A MALFUNCTION OF THE GATE. THE TUBE A IS RELEASED BY THE SRM AS TUBE B DUE TO A MISCOMMUNICATION BETWEEN THE SRM FIRMWARE AND THE AUTOMATION SOFTWARE. IN THE CASE REPORTED FROM THE FIELD TUBE B DID NOT HAVE PENDING TEST ORDERS SO BOTH THE SAMPLE TUBES (THE REAL TUBE B AND THE TUBE A WRONGLY IDENTIFIED AS TUBE B) WERE DIRECTLY SENT TO THE SRM. THERE WAS A DELAY IN THE ADDITIONAL TESTS ORDERED ON TUBE A SINCE THE AUTOMATION SYSTEM LOSES THE TRACEABILITY OF THIS SAMPLE TUBE. THE ADDITIONAL TEST ORDERS REMAINED PENDING ON THE AUTOMATION SOFTWARE AND THERE WAS ALREADY AVAILABLE ANOTHER SAMPLE TUBE OF THE SAME PATIENT TO COMPLETE THE TESTS. THE INVESTIGATION IS STILL ONGOING TO IDENTIFY POSSIBLE ADDITIONAL IMPACTS CAUSED BY SAMPLES ID MISCOMMUNICATION IN THE SCENARIO DESCRIBED ABOVE AND POSSIBLE OTHER MODULES IMPACTED BY THE SAME BUG.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (3010825766-2022-00006) WAS SUBMITTED ON OCTOBER 28TH, 2022. ADDITIONAL INFORMATION: THE INVESTIGATION CONFIRMED THAT THE EVENT IS CAUSED BY A FIRMWARE BUG. FOR ALL THE IMPACTED MODULES THE ISSUE WILL BE FIXED WITH A NEW FIRMWARE VERSION AND THE UPGRADE WILL BE MANDATORY ON THE FIELD. INPECO HAS SUBMITTED A CORRECTION AND REMOVAL REPORT TO FDA RELATED TO THIS ISSUE (REFERENCE CODE: 3010825766 - 03/03/23 - 001 - C) UPON THE RELEASE OF FIXING FIRMWARE VERSIONS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT, WHEN THEY ORDERED THE RETRIEVE OF A SAMPLE TUBE FROM THE STORAGE AND RETRIEVAL MODULE (SRM) OF THE APTIO AUTOMATION, THE SAMPLE TUBE WAS LOST. THE STORAGE AND RETRIEVAL MODULE STORES SAMPLE TUBES FROM THE AUTOMATION SYSTEM IN A TEMPERATURE CONTROLLED AND PROTECTED ENVIRONMENT. THE EVENT CAUSED A DELAY IN THE EXECUTION OF ADDITIONAL TESTS ORDERED ON THE SAMPLE TUBE. THE CUSTOMER DID NOT REPORT ANY CONSEQUENCE ON THE STATE OF HEALTH AND MEDICAL TREATMENT OF THE INVOLVED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2871845 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown