MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Model Number	TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The fse went to the doctor on (b)(6) 2020 (three days after event).During this visit, the doctor prescribed a steroid (name not provided) and instructed the fse to take 2 days of leave from work to rest the elbow.As of (b)(6) 2020, the fse reported that his elbow was still sore and was wearing an elbow brace.The fse was not given any work limitation by the doctor.No erroneous results were generated as a result of this event.There was no impact or change to patient treatment.There was no instrument malfunction identified that resulted in this event.The fse aggravated a pre-existing injury while performing a preventative maintenance.Internal bec internal identifier - case (b)(4).
Event or Problem Description
The beckman coulter (bec) field service engineer (fse) was at a customer site performing a scheduled preventative maintenance (pm) on their unicel dxh800 instrument.During the course of performing the pm, the fse experienced elbow pain to the point where he could not continue to work.The fse had been experiencing elbow soreness for a couple of weeks before performing the pm.The fse was attempting to remove retaining ring on the distribution valve assembly inside the customer¿s dxh800 instrument during pm by twisting it off by hand.This twisting action inflamed the already sore elbow area.The fse had been following his doctor¿s previous recommendation of icing the elbow.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• MDR Report Key: 9709094
• Report Number: 1061932-2020-00011
• Device Sequence Number: 3654238
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)170908
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other