BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCELERATOR A3600

    MDR report key: 18090543 · Received November 8, 2023

    Report

    Report Number
    3010825766-2023-00013
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 6, 2023
    Report Date
    May 29, 2024
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172341001
    PMA / PMN Number
    K121012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE ASSOCIATION OF THE SAMPLE TUBE TO THE WRONG CARRIER WAS CAUSED BY A CARRIER JAM AT THE CENTRIFUGE MODULE EXIT WHICH LED THE CARRIERS ALREADY RELEASED TO BE PUSHED BACK ON THE ANTENNA AT THE LOAD GATE. THE DISTRIBUTOR FIELD SERVICE ENGINEER (FSE) VERIFIED THE ANTENNA AND STOP GATE FUNCTIONING AND ALIGNMENT. HE DISCOVERED THAT THE TRACK PROFILE WAS NOT CORRECTLY PLACED BY FSE PREVENTING THE SMOOTH PASSAGE OF THE CARRIERS. HE RESEATED THE EXIT LANE ASSEMBLY AND REPLACED THE BUFFER LANE STOP GATE AND DIVERTER FIXING THE CARRIER ROUTING ISSUES. THE SERVICE MANUAL ALREADY DESCRIBES HOW TO CORRECTLY INSTALL THE EXIT LANE ASSEMBLY. NO ADDITIONAL ACTIONS ARE FORESEEN.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    A CUSTOMER OUTSIDE US REPORTED A SAMPLE TUBE ID MISMATCH OCCURRED AT THE CENTRIFUGE MODULE WHICH CONNECTS THE AUTOMATION SYSTEM TRACK TO THE THIRD PARTY'S CENTRIFUGE. THE INVOLVED SAMPLE TUBES WERE A TUBE WHICH SHOULD HAVE BEEN DIVERTED INTO THE CENTRIFUGE MODULE BUT REMAINED ON THE MAIN TRACK (TUBE A) AND A SAMPLE TUBE LOADED INTO THE CENTRIFUGE (TUBE B). THE CARRIER WHICH WAS PHYSICALLY TRANSPORTING TUBE A WAS ERRONEOUSLY ASSOCIATED TO TUBE B. TUBE A WAS FLAGGED WITH ERROR SC06D "TUBE LOST IN PICK AND PLACE MODULE". THE REAL TUBE A WAS SENT TO THE ANALYZERS TO BE TESTED ACCORDING TO THE TEST ORDERS RECEIVED FOR TUBE B. THE TEST ORDERED FOR TUBE B SHOULD HAVE BEEN EXECUTED ON A CENTRIFUGED SAMPLE (SERUM OR PLASMA) WHILE TUBE A WAS STILL A WHOLE BLOOD SAMPLE. THE OBTAINED RESULTS WERE OUT OF NORMAL RANGE. THE SAMPLE TUBE WAS SORTED IN A RACK OF IOM#2. WHEN THE OPERATOR PERFORMED THE VISUAL CHECK ON THE SAMPLE BEFORE RE-RUN, HE BECAME AWARE OF THE SID MISMATCH ISSUE. HE BLOCKED THE RESULTS OBTAINED FROM TUBE A. WHEN THE REAL TUBE B WAS THEN RELEASED BY THE CENTRIFUGE MODULE, IT WAS FLAGGED AS DUPLICATE (SC00E) AND UNLOADED INTO THE PRIORITY OUTPUT RACK DEDICATED TO SAMPLE TUBES WITH ERROR MESSAGES AT THE INPUT OUTPUT MODULE (IOM#1) TO BE MANUALLY MANAGED BY THE OPERATORS. BOTH TUBE A AND TUBE B WERE RE-CENTRIFUGED IN A STANDALONE CENTRIFUGE AND THE SAMPLES WERE MANUALLY PLACED INTO THE ANALYZER FOR THE ASSAYS RUN. ACCORDING TO THE PROVIDED INFORMATION THERE WERE NO IMPACTS ON THE INVOLVED PATIENTS: NO MEDICATION NOR TREATMENT WAS DELAYED OR CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744710 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown