MAUDE Adverse Event Report: BECKMAN COULTER BIOMEDICAL GMBH AUTOMATE 1250 SAMPLE PROCESSING SYSTEM; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number ODL25125

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Laceration(s) (1946); Injury (2348); Suture Abrasion (2497)

Event Date 06/30/2017

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

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.

• Brand Name: AUTOMATE 1250 SAMPLE PROCESSING SYSTEM
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen, bayern 81379 ; GM 81379
• Manufacturer (Section G): BECKMAN COULTER BIOMEDICAL GMBH; ruppert-mayer-str. 44; muenchen, 81379 ; GM 81379
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7142649714
• MDR Report Key: 6822694
• MDR Text Key: 83726914
• Report Number: 3006655511-2017-00001
• 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: company representative
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 06/30/2017

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: ODL25125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2009
• 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