BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APTIO AUTOMATION

    MDR report key: 11642219 · Received April 9, 2021

    Report

    Report Number
    3010825766-2021-00007
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    February 25, 2021
    Report Date
    December 17, 2021
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172342008
    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 (3010825766-2021-00007) HAS BEEN SUBMITTED ON (B)(6) 2021. ADDITIONAL INFORMATION: ACCORDING TO THE INVESTIGATION, THE ROOT CAUSE OF THE EVENT IS A FIRMWARE BUG WHICH MIGHT LEAD TO THE RELEASE OF A SAMPLE TUBE WITH THE WRONG ID FROM THE STAGO STAR INTERFACE MODULE. INPECO HAS RELEASED A NEW FIRMWARE VERSION. THE UPGRADE TO THIS VERSION HAS NOT BEEN EVALUATED MANDATORY IN TERMS OF RECALL. THE PROBABILITY OF OCCURRENCE OF THE ISSUE HAS BEEN EVALUATED ALREADY IMPROBABLE SINCE NO OTHER CASES HAVE BEEN REPORTED FROM THE FIELD AND IT HAS NOT BEEN POSSIBLE TO REPRODUCE THE EVENT IN HOUSE. MOREOVER, THE OPERATORS HAVE THE POSSIBILITY TO BECOME AWARE OF THE ISSUE THANKS TO THE ERROR SC00E "DUPLICATE SAMPLE ID" ASSOCIATED TO THE SAMPLE TUBE WRONGLY IDENTIFIED AS DUPLICATE.

    Additional Manufacturer Narrative · 1

    FROM THE LOG FILES ANALYSIS PROVIDED BY THE PRODUCT DISTRIBUTOR, IT WAS FOUND THAT: SID (B)(6) ARRIVED AT THE STAGO STA-R ANALYZER FIRST, FOLLOWED BY SID (B)(6). AFTER THE PROCESSING AT THE ANALYZER, THE SID (B)(6) WAS RELEASED BUT IT WAS RETURNED WITH THE SID OF THE FOLLOWING SAMPLE TUBE. THEN, THE SID (B)(6) WAS PROCESSED BY THE ANALYZER. THE SID WAS CORRECTLY READ AT THE BARCODE READER AT THE EXIT OF THE MODULE, BUT IT WAS RELEASED WITH THE ERROR SC00E "DUPLICATE SAMPLE ID". THE REAL SID (B)(6) FOLLOWED THE PATH FOR SID (B)(6): IN THIS CASE, IT WAS SENT TO SORTING RACK OF IOM SINCE IT DID NOT HAVE ANY PENDING TEST ORDER TO BE PERFORMED. THE REAL SID (B)(6) WAS SENT TO PRIORITY OUTPUT RACK OF THE IOM SINCE IT WAS FLAGGED WITH THE ERROR SC00E. IN BOTH CASES, SINCE THE SAMPLE TUBES WERE SENT TO SPECIFIC RACKS, THEY SHALL BE MANUALLY MANAGED BY THE LABORATORY OPERATOR, WHO BECAME AWARE OF THE EVENT. NO IMPACT ON PATIENT CARE WAS REPORTED, AND NO INCORRECT RESULTS WERE GENERATED. THE INVESTIGATION IS STILL ONGOING TO IDENTIFY THE ROOT CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A TUBE WITH SAMPLE IDENTIFICATION NUMBER (SID) (B)(6) WAS RELEASED BY THE STAGO STA-R ANALYZER INTERFACE MODULE WITH THE ERROR SC00E "DUPLICATE SAMPLE ID". ACCORDING TO THE GRAPHICAL USER INTERFACE, THAT SID WAS LOCATED IN A SORTING RACK OF THE INPUT OUTPUT MODULE (IOM), BUT WHEN THE OPERATOR TOOK THE SAMPLE TUBE FROM THE SORTING RACK, HE SAW THAT THE SID WAS NOT (B)(6). THE REAL SID (B)(6) WAS IN ANOTHER RACK OF THE IOM NAMED (B)(6). THE STAGO STA-R ANALYZER IS NOT UNDER INPECO RESPONSIBILITY AND IT IS CONNECTED TO THE INPECO APTIO AUTOMATION SYSTEM THROUGH AN INTERFACE MODULE, COMPOSED BY A "PICK AND PLACE" ROBOTIC SAMPLE MOVING DEVICE DESIGNED TO TRANSFER THE SAMPLE TUBES TO AND FROM THE ANALYZER. THE INTERFACE MODULE HAS A BARCODE READER AT THE EXIT OF THE MODULE, WHICH READS THE SID ON THE LABEL OF THE SAMPLE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537490 APTIO AUTOMATION LABORATORY AUTOMATION SYSTEM CEM INPECO SA AP2 07640172342008

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown