BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A3600

    MDR report key: 11322547 · Received February 12, 2021

    Report

    Report Number
    3010825766-2021-00001
    Event Type
    Injury
    Date Received
    February 12, 2021
    Report Date
    March 31, 2021
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT (3010825766-2021-00001) HAS BEEN SUBMITTED ON FEBRUARY 12TH, 2021. INPECO REQUESTED ADDITIONAL INFORMATION TO THE CUSTOMER MULTIPLE TIMES IN ORDER TO IDENTIFY IN WHICH PART OF THE AUTOMATION SYSTEM THE TECHNICIAN GOT INJURED AND TO HAVE AN UPDATE REGARDING THE TECHNICIAN'S HEALTH CONDITIONS AND RECEIVED MEDICAL TREATMENTS. THE CUSTOMER HAS NOT REPLIED AND HAS NOT PROVIDED THE DATA NEEDED TO CONTINUE THE INVESTIGATION. WITH THE PROVIDED INFORMATION THE EVENT HAS BEEN EVALUATED THE RESULT OF A USER ERROR SINCE THE TECHNICIAN REMOVED THE SAFETY SHIELDS AND COVERS WHILE THE AUTOMATION SYSTEM WAS ON-LINE DISREGARDING THE INSTRUCTIONS IN THE OPERATION MANUAL. THE AUTOMATION SYSTEM IS PERFORMING ACCORDING TO THE SPECIFICATIONS. NO FURTHER ACTIONS ARE REQUIRED. THE ADVERSE EVENT PROBLEM CODES (SECTION H6) HAVE BEEN UPDATED. THE COMPONENT CODE IS NOT FILLED IN SINCE THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT THE INVOLVED AUTOMATION SYSTEM PART.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ANY IMAGE TO BETTER IDENTIFY IN WHICH PART OF THE AUTOMATION SYSTEM THE TECHNICIAN GOT INJURED. THE TRACK MODULE IS COVERED WITH PANELS AND THE MOVING PARTS BEHIND THE PANELS ARE COVERED WITH PROTECTIVE SHIELDS THAT CAN BE REMOVED ONLY BY SERVICE PERSONNEL. THE LABELING HAS BEEN REVIEWED AND IT HAS BEEN CONSIDERED ADEQUATE. THE OPERATIONS MANUAL ALREADY INSTRUCTS THE OPERATORS NOT TO OPEN OR REMOVE SAFETY SHIELDS AND COVERS DURING SAMPLE PROCESSING OR IF THE AUTOMATION MODULE IS ON-LINE AND IT WARNS THE OPERATORS TO USE CAUTION WHEN ACCESSING PARTS OF THE MODULE NORMALLY PROTECTED BY COVERS SINCE SHARP SURFACES CAN BE REACHED. THE INVESTIGATION WILL BE CONTINUED IF ADDITIONAL INFORMATION IS RECEIVED FROM FIELD.

    Description of Event or Problem · 1

    A LABORATORY TECHNICIAN INJURED HER HAND WHILE SHE WAS TRYING TO RETRIEVE SOME SAMPLE TUBES LOST AT THE STORAGE RETRIEVE MODULE AND ALLEGEDLY FALLEN UNDER THE AUTOMATION SYSTEM TRACK. THE INVOLVED TUBES WOULD BE CAPPED OR SEALED SO THEY DID NOT CAUSE ANY SAMPLE SPILLAGE. THE TECHNICIAN REMOVED THE PANEL AND SHE DID NOT PAUSE THE TRACK MOVEMENT. WHILE SHE WAS REACHING THE AREA TO CHECK FOR MISSING SAMPLE TUBES HER HAND BECAME LODGED AND SHE INJURED HER RIGHT INDEX FINGER (SKIN ABRASION AND NAIL DAMAGE). THE TECHNICIAN WAS WEARING GLOVES. AT THE ER, THEY CLEANED THE WOUND AND ADMINISTERED A TETANUS SHOT. THE XRAY RULED OUT ANY FRACTURE. THE INJURY IS MONITORED FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220622 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA ACP 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other