BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A 3600

    MDR report key: 17955313 · Received October 18, 2023

    Report

    Report Number
    3010825766-2023-00011
    Event Type
    Injury
    Date Received
    October 18, 2023
    Report Date
    October 18, 2023
    Manufacturer
    INPECO SA
    Product Code
    CEM
    UDI-DI
    07640172341001
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE LABORATORY EMPLOYEE WAS DOING THE RECOVERY OF ERROR 2185 "TIP BLOCKED IN CHAMBER" WHEN HE/HER INJURED HIM/HERSELF. ACCORDING TO THE INFORMATION PROVIDED BY THE CLIENT, THE EMPLOYEE IS UNDER MEDICAL CARE, AND HE/SHE IS ABSENT FROM WORK 17 DAYS AS OF (B)(6). IT IS STILL UNKNOWN IF OTHER MEDICAL TREATMENTS HAVE BEEN PERFORMED. THE FIRST INSTRUCTION OF THE TROUBLESHOOTING PROCEDURE IS "CONTACT THE SERVICE ASSISTANT TO PERFORM THE FOLLOWING STEPS", BUT HE/HER DID NOT DO IT. MOREOVER, HE/HER REMOVED THE LONG UPPER SIDE PANEL, THAT WAS NOT TO BE REMOVED ACCORDING TO THE PROCEDURE ITSELF. THEREFORE, THE DESIGN OF THE ALIQUOTER MODULE'S PANEL AND THE PROCEDURE TO HANDLE IT ARE CONSIDERED ADEQUATE. NO ACTIONS ARE FORESEEN TO BE TAKEN BY INPECO.

    Description of Event or Problem · 0

    THE CLIENT REPORTED THAT A LABORATORY OPERATOR WAS INJURED DURING TROUBLESHOOTING OF A "TIP CHAMBER JAM" ON THE ALIQUOTER MODULE. THE EMPLOYEE REMOVED THE LONG UPPER SIDE PANEL AND HIT HIM/HERSELF ON THE JAW CAUSING A DISLOCATION. THE EMPLOYEE VISITED THE EMERGENCY DEPARTMENT AND HAS BEEN OFF WORK SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203179 ACCELERATOR A 3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other