MAUDE Adverse Event Report: BECKMAN COULTER AUTOMATE 2550 LAB INSTRUMENT; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Model Number	AUTOMATE 2550
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	07/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) went onsite on (b)(4) 2018 and evaluated the instrument.The fse did not find any malfunction of the device.The operator failed to depressurize the system before attempting to remove the blockage.The instructions for use clearly state to depressurize the compressor in case of a tube jam.(b)(4).
Event or Problem Description
On (b)(6) 2018, a user incorrectly tried to remove tubes that were blocked/jammed from inside the automate 2550 lab instrument.The user's thumb became "blocked" by the roller resulting in a bruised thumb.The user received a medical review and prescription anti-inflammatory treatment.

• Brand Name: AUTOMATE 2550 LAB INSTRUMENT
• Common Device Name: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• MDR Report Key: 7710877
• Report Number: 3006655511-2018-01000
• Device Sequence Number: 11408114
• Product Code: JQP
• UDI-Device Identifier: 15099590364083
• UDI-Public: (01)15099590364083(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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
• Operator of Device: Health Professional
• Device Model Number: AUTOMATE 2550
• Device Catalogue Number: ODL25255
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/23/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other