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

Model Number	TN DXH 800 HEMATOLOGY SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The orthopedic specialistprovided a diagnosis of possible slap/bicep/rotator cuff tear and prescribed physical therapy multiple times a week as well medication for the pain.There were no work restrictions and the fse did not take any time off as a result of his injury.A restrospective review of complaints going back to 01-jul-2023 was done and there were no additional similar events reported.The information available suggests this is an isolated incident.Bec internal identifier - (b)(4).
Event or Problem Description
The bec field service manager reported that a bec field service engineer (fse) was injured while troubleshooting the customer¿s dxh 800 hematology instrument.During troubleshooting the customer's dxh 800 hematology instrument, the fse injured his right shoulder due to lifting a cover on the instrument several times.The door needs to be removed each time to service the area and needed to be placed back on to engage the safety measures on the unit.Per incident report (b)(4), the field service manager indicated that the fse placed the right hand on back of instrument door from lower right, with the left hand on top of the left front side of the door, lifted door with both hands and felt popping in right shoulder.The fse was initially seen by their primary care physician (pcp) on (b)(6) 2024.The pcp did not provide a diagnosis and imaging was not done of the affected area.The fse was instructed to use over the counter (otc) cream for pain relief and told to follow up with an orthopedic specialist and get x-rays of the affected area.There were no work restrictions required by the pcp.The fse received x-rays on (b)(6) 2024 and the results of the imaging were considered normal.On (b)(6) 2024, the fse was seen by an orthopedic specialist, who provided the following diagnosis: possible slap/bicep/rotator cuff tear and prescribed physical therapy multiple times a week as well medication for the pain.

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea CA
• Manufacturer (Section G): BECKMAN COULTER, INC; 11800 sw 147th avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 19934793
• Report Number: 1061932-2024-00010
• Device Sequence Number: 20072065
• Product Code: GKZ
• UDI-Device Identifier: 15099590672423
• UDI-Public: (01)15099590672423(11)170811
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K140911
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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: Other
• Device Model Number: TN DXH 800 HEMATOLOGY SYSTEM
• Device Catalogue Number: 629029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown