BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A3600

    MDR report key: 17669399 · Received September 1, 2023

    Report

    Report Number
    3010825766-2023-00008
    Event Type
    Injury
    Date Received
    September 1, 2023
    Report Date
    October 12, 2023
    Manufacturer
    INPECO SA
    Product Code
    CEM
    PMA / PMN Number
    K121012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SERVICE IS TRAINED PERSONNEL FOR THE INSTALLATION, USE AND MAINTENANCE OF THE AUTOMATION SYSTEM. THE SERVICE MANUAL ALREADY RECOMMENDS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN WORKING IN A LAB ENVIRONMENT, WHICH MAY INCLUDE ANTI-CUTTING GLOVES HANDLING METAL PANEL. THE FSE SHOULD HAVE CLEANED THE SAMPLE RESIDUES ON THE TRACK PANEL AND SHOULD HAVE REMOVED THE PANEL BEFORE WORKING ON THE PNEUMATIC TUBING IN ORDER TO WORK IN A SAFE WAY. THE CURRENT DESIGN OF THE LATERAL PANEL IS CONSIDERED ADEQUATE: THE PANELS ARE CHECKED FOR SHARP EDGES BY THE SUPPLIER. THE SERVICE MANUAL IS COMPLETE. AN ADDITIONAL FOLLOW UP IS FORESEEN WHEN THE FSE WILL REPEAT THE BLOOD ANALYSIS.

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS SENT ON SEPTEMBER 1ST, 2023. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 14TH, 2023 THE FSE REPEATED THE BLOOD ANALYSIS FOR THE INFECTIOUS DISEASE PANEL TEST AND IT ALL CAME BACK NEGATIVE. NO ADDITIONAL ACTIONS ARE FORESEEN.

    Description of Event or Problem · 0

    DURING THE DECOMMISSIONING OF A COBAS 8000 INTERFACE MODULE, A FIELD SERVICE ENGINEER (FSE) GOT INJURED REMOVING SOME OF THE PNEUMATIC TUBING. SPECIFICALLY HE SCRATCHED HIS HAND ON THE TRACK PANEL WHICH HAD EVIDENCE OF SPECIMEN SPLASHING. THE FSE WAS WEARING THE LABORATORY COAT AND LATEX GLOVES, BUT THE GLOVES GOT PIERCED AND THE EXPOSED SKIN WAS SUPERFICIALLY SCRATCHED DRAWING BLOOD. THE FSE WASHED HIS HANDS AND USED ALCOHOL SWABS ON THE INFECTED AREA. AS A PRECAUTION, THE HOSPITAL DREW BLOOD TO TEST FOR A BASELINE PANEL INCLUDING HEPATITIS AND HIV WHICH ALL CAME BACK NEGATIVE. ADDITIONALLY, THE FSE RECEIVED A TETANUS SHOT AND WAS PRESCRIBED POST EXPOSURE PROPHYLAXIS TO TAKE FOR TWENTY-EIGHT DAYS FOLLOWING EXPOSURE AND RETURN TO FAMILY DOCTOR FOR REPEAT BLOOD WORK TO ENSURE THE RESULTS ARE STILL NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125153 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM CEM INPECO SA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other