BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATE 1250 SAMPLE PROCESSING SYSTEM

    MDR report key: 6822694 · Received August 25, 2017

    Report

    Report Number
    3006655511-2017-00001
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    June 30, 2017
    Report Date
    June 30, 2017
    Manufacturer
    BECKMAN COULTER BIOMEDICAL GMBH
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED BY A BECKMAN COULTER EMPLOYEE WHO'S OFFICE IS LOCATED IN (B)(4). THIS EVENT OCCURRED AT THE CUSTOMER'S FACILITY LOCATED IN (B)(6). THIS INCIDENT WAS CAUSED BY A MISCOMMUNICATION BY A BECKMAN COULTER SERVICE ENGINEER AND ANOTHER ASSOCIATE DURING THE DECOMMISSIONING PROCESS OF THE AUTOMATE 1250. BASED ON THE AVAILABLE INFORMATION, THERE'S NO EVIDENCE TO SUGGEST A SYSTEM MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    A BECKMAN COULTER SERVICE ENGINEER'S RIGHT INDEX FINGER GOT PINCHED AND BLED DURING THE DECOMMISSIONING PROCESS OF THE AUTOMATE 1250 INSTRUMENT. THE INCIDENT TOOK PLACE AT THE CUSTOMER'S LABORATORY LOCATED IN (B)(6). DURING THE MOVING OF THE INSTRUMENT, A COMMAND BETWEEN THE SERVICE ENGINEER AND ANOTHER ASSOCIATE WAS MISCOMMUNICATED / MISUNDERSTOOD, WHICH CAUSED AN UNINTENTIONAL MOVE BY THE ASSOCIATE THAT LEAD THE INSTRUMENT TO JAM THE SERVICE ENGINEER'S FINGER. THE SERVICE ENGINEER SOUGHT MEDICAL ATTENTION AND RECEIVED SUTURE ON THE WOUND. HE ALSO RECEIVED A TETANUS VACCINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602506 AUTOMATE 1250 SAMPLE PROCESSING SYSTEM CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP BECKMAN COULTER BIOMEDICAL GMBH NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention