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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 01/13/2020

Event Type  Injury  

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 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
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 9709094
• MDR Text Key: 192437183
• Report Number: 1061932-2020-00011
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)170908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140911
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: TN,DXH 800HEMATOLOGY SYSTEM WITH FLOOR STAND
• Device Catalogue Number: B24802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2020
• Initial Date FDA Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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): Other