BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCELERATOR A3600

    MDR report key: 22953920 · Received September 3, 2025

    Report

    Report Number
    3010825766-2025-00005
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 4, 2025
    Report Date
    October 21, 2025
    Manufacturer
    INPECO SA
    Product Code
    JQP
    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

    ACCORDING TO THE INFORMATION PROVIDED BY THE DISTRIBUTOR, THE FSE HAS RETURNED TO WORK ON (B)(6) 2025. THE INITIAL INJURY WAS NOT OUTWARDLY SEVERE (FLUSHED EYE). THE FSE CONSULTED A DOCTOR WHO ADVISED TO CONTINUE FLUSHING. ON SEP. 23RD, THE DISTRIBUTOR CONFIRMED THAT THE FSE TOOK BLOOD TESTS, AND THE RESULTS WERE NEGATIVE. THE "HEALTH AND SAFETY" DEPARTMENT SHE TALKED WITH DID NOT HAVE FURTHER INSTRUCTIONS FOR HER. THE FSE HAS TO RETURN IN SIX MONTHS FOR A FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    ACCORDING TO INPECO'S DOCUMENTATION, THE ERROR CODE 0FFA "TUBE DROP FAILURE" IS A RED ERROR CONDITION, WHOM RECOVERY INDICATES TO CONTACT THE SERVICE ASSISTANCE, AS HAPPENED. THE FSE INVOLVED WAS NOT WEARING APPROPRIATE PPE. INPECO VERIFIED THE COMPLETION OF THE INFORMATION PROVIDED IN THE SERVICE MANUAL: THE "SATEFY COMPLIANCE" SECTION ALREADY STATES THAT IN CASE OF POTENTIAL BIOHAZARD EXPOSURE IT IS NECESSARY TO FOLLOW LABORATORY SAFETY PROCEDURES AND GUIDELINES FOR PERSONAL PROTECTION, INCLUDING THE USE OF A GOWN, MASK/VISOR, VINYL GLOVES, HAND SANITIZER OR SHOE COVERS, AND CLINICAL LABORATORY SAFETY. THEREFORE, INPECO DOES NOT PLAN TO IMPLEMENT ANY DESIGN CHANGE TO THE DEVICE. AT THE MOMENT, NO FURTHER INFORMATION REGARDING THE CLINICAL CONDITION OF THE FSE IS AVAILABLE. INPECO WILL PROVIDE ADDITIONAL DETAILS COMING FROM THE INVESTIGATION.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A TUBE GOT STUCK IN THE STORAGE MODULE (SRM) WASTE CHUTE. AFTER HAVING REMOVED THE TUBE, THE AUTOMATION SYSTEM BEGAN TO NOTIFY TUBE DROP ERRORS. THE FIELD SERVICE ENGINEER (FSE) SUSPECTED THE SENSOR MAY HAVE BEEN CONTAMINATED. THE FSE CLEANED THE SENSOR (THAT IS LOCATED IN THE CHUTE), THEN OBSERVED TUBES GOING TO WASTE, IN ORDER TO VERIFY THE ISSUE WAS RESOLVED. DURING THIS TIME, ONE TUBE CAME DOWN, THE FOIL TOP BECAME LOOSE, AND THE CONTENTS OF THE TUBE SPLASHED THE FSE IN THE FACE. THE FSE CLEANED THE EYE WITH WATER AND CONTACTED A MEDICAL DOCTOR FOR ADVICE. THE FSE WAS ADVISED TO REMOVE CONTACT LENSES AND CLEAN WITH SALINE. ACCORDING TO THE INFORMATION AVAILABLE TO DATE, THE FSE PLANS TO GET TESTED FOR INFECTIOUS DISEASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293096 ACCELERATOR A3600 LABORATORY AUTOMATION SYSTEM JQP INPECO SA 07640172341001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other