MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE 2500 SAMPLE PROCESSING SYSTEM; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number ODL25250

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Headache (1880); Pain (1994); Numbness (2415)

Event Date 01/15/2015

Event Type  Injury  

Event Description

On 06/04/2015, the customer reported to beckman coulter (bec) field service engineer (fse) that on (b)(6) 2015, one of their lab technicians was trying to retrieve a tube from the gripper and accidentally pressed the "initialize" key on the control pad, on the automate 2500 sample processing system.This initiated the robotic arm to hit the frontal left side of the lab technician's head.The lab technician had a contusion and a small cut that was superficial.The lab technician was treated with a bandage for the small cut at the emergency room (er) and was under work restriction for one day.On (b)(6) 2015, the lab technician revisited the physician and was granted mandatory work restriction until (b)(6) 2015.On (b)(6) 2015, the lab technician was referred to a neurologist, and diagnosis was unknown.The lab technician was not admitted to the hospital; she did not receive any treatment nor was prescribed any medication.The lab technician reported to continue to have intermittent headaches, migraines, neck pain, and numbness in fingers, and has been on medical leave of absence from (b)(6) 2015 to the current date ((b)(6) 2015).However, the connection between the incident and medical leave of absence has not been confirmed.

Manufacturer Narrative

The incident was caused by the employee trying to retrieve a tube from the gripper and accidentally pressed "initialize" key on the control pad of their automate 2500 sample processing system.This initiated the robotic arm to hit the employee's head.The customer admitted to have caused the error and did not request service.Based on the available information, there's no evidence to suggest a system malfunction.

• Brand Name: AUTOMATE 2500 SAMPLE PROCESSING SYSTEM
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea 92821 800
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen, 8137 9; GM 81379
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7142649714
• MDR Report Key: 4880542
• MDR Text Key: 6258869
• Report Number: 3006655511-2015-00002
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ODL25250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention