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

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

This incident was caused by a customer trying to reach into the automate 2500 while the system was in operation.This event is attributed to user error per automate 2500 family sample processing system instruction for use (reference pn (b)(4); may 2016): - safety notice - avoid moving parts: "while the system is in operation, do not touch or go close to any moving parts.Close protective guards and covers during operation.Failure to close covers correctly can cause injury or incorrect results." - preconditions before you start - "caution - always run the automate system with all covers locked and the doors and interlock doors always closed and secured to prevent injury." reference label (b)(4): "stop the system software application before opening protective covers.Otherwise you risk being injured by moving parts.When you lift any of the protective covers, make sure that it locks in the raised position before releasing it." (b)(6).(b)(4).

Event Description

On (b)(6) 2016, a customer in (b)(6) reported to beckman coulter that he sustained an injury as he reached into the automate 2500 sample processing system while the instrument was in operation mode.The moving gripper hit against the customer's arm and head.The customer was treated in the emergency room, with a pad (bandage) for a cut on his head and he was under work restriction for two days.

• 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 8000
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen, bayern 81379 ; GM 81379
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7149613796
• MDR Report Key: 5989106
• MDR Text Key: 55989208
• Report Number: 3006655511-2016-00003
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/20/2016

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 Model Number: N/A
• Device Catalogue Number: ODL07039
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2016
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention