BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 11596191 · Received March 31, 2021

    Report

    Report Number
    3010825766-2021-00006
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Report Date
    September 29, 2021
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (3010825766-2021-00006) WAS SUBMITTED ON MARCH 31ST, 2021. ADDITIONAL INFORMATION: ACCORDING TO THE INVESTIGATION, THE FIRMWARE (FW) OF THE AUTOMATION SYSTEM INTERFACE MODULE TO ADVIA CENTAUR XP/XPT MAY LEAD, IN SPECIFIC AND RARE CASES, TO AN INCORRECT ASSOCIATION OF TEST RESULT(S) TO SAMPLE ID. THE ISSUE OCCURS AS A CONSEQUENCE OF A SAMPLE TUBE TO BE PROCESSED BY THE ADVIA CENTAUR XP/XPT THAT IS NOT DIVERTED INTO THE INTERFACE MODULE DUE TO A MECHANICAL ISSUE OR DUE TO AN OBSTRUCTION. UPON THIS SCENARIO, ONE OF THE FOLLOWING SAMPLE TUBE(S) THAT IS DIVERTED INTO THE INTERFACE MODULE IN ORDER TO BE PROCESSED BY THE ADVIA CENTAUR XP/XPT MAY BE RELEASED FROM THE INTERFACE MODULE AND FLAGGED WITH THE ERROR CODE 3160 OR 0D60 "SAMPLING NOT SUCCESSFUL" AND WITH TEST RESULTS OBTAINED FROM ANOTHER SAMPLE TUBE. ACCORDING TO THE DEFAULT AUTOMATION SYSTEM CONFIGURATION, THE SAMPLE TUBE FLAGGED WITH ERROR CODE 3160 OR THE ERROR CODE 0D60 IS SENT INTO AN INPUT/OUTPUT MODULE PRIORITY OUTPUT RACK TO BE MANUALLY MANAGED BY THE OPERATORS. THE ROOT CAUSE OF THE ISSUE IS A BUG IN THE FIRMWARE OF THE AUTOMATION SYSTEM INTERFACE MODULE TO THE ADVIA CENTAUR XP/XPT. INPECO HAS RELEASED NEW FIRMWARE VERSIONS TO CORRECT THE ISSUE. THE UPGRADE WILL BE MANDATORY ON THE FIELD FOR ALL THE CUSTOMERS WITH THE IMPACTED INTERFACE MODULES. INPECO HAS SUBMITTED THE RECALL #3010825766- 090621 - 001 - C.

    Additional Manufacturer Narrative · 1

    IN BOTH THE REPORTED OCCURRENCES, THE CUSTOMER STATED THAT THE SAMPLE TUBE WAS DIVERTED TO THE ADVIA CENTAUR INTERFACE MODULE IN ORDER TO BE TESTED AT THE ANALYZER. THE SAMPLE TUBE WAS RELEASED WITH THE WARNING 3160 "SAMPLING NOT SUCCESSFUL" BEFORE THE SAMPLING COMPLETION. IT IS UNDER INVESTIGATION IF THE SAMPLING WAS PERFORMED ON THE FOLLOWING SAMPLE TUBE IN THE INTERFACE MODULE QUEUE AND THE RESULTS OBTAINED WERE ASSOCIATED TO THE FIRST TUBE. DUE TO THE WARNING 3160 THE SAMPLE TUBE WAS SENT TO A DEDICATED RACK (PRIORITY OUTPUT) OF THE INPUT OUTPUT MODULE IN ORDER TO BE MANUALLY MANAGED BY THE LABORATORY OPERATOR. THE LABORATORY OPERATOR IS A TRAINED PERSON ON THE USE OF THE AUTOMATION SYSTEM, SO HE/SHE KNOWS THAT WHEN A SAMPLE TUBE IS RETURNED TO PRIORITY OUTPUT THIS MEANS THAT AN ERROR IS ASSOCIATED TO THE TUBE AND IT SHOULD BE MANUALLY HANDLED. NO IMPACT ON PATIENT CARE WAS REPORTED. THE CUSTOMER DECIDED TO SET OFFLINE THE INTERFACE MODULE. THE INVESTIGATION IS STILL ONGOING TO IDENTIFY THE ROOT CAUSE. THIS REPORT CONTAINS NEW OCCURRENCES OF THE EVENT PREVIOUSLY REPORTED IN 3010825766-2020-00008.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO OCCURRENCES (ON (B)(6) 2021) ABOUT DISCREPANT RESULTS OBTAINED FOR SAMPLE TUBES PROCESSED AT THE ADVIA CENTAUR XPT ANALYZER CONNECTED TO THE INPECO APTIO AUTOMATION SYSTEM THROUGH AN INTERFACE MODULE. THE ADVIA CENTAUR XPT IS A THIRD-PARTY ANALYZER NOT UNDER INPECO RESPONSIBILITY. THE CUSTOMER DID NOT REPORT ANY IMPACT ON PATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496017 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1