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

Model Number	TN UNICEL? DXH SLIDEMAKER STAINER
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	02/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During removal of the sample transport module (stm) on the unicel dxh slidemaker stainer (product number: 775222, serial number: (b)(6) , the module became lodged on the guide rail.The beckman coulter (bec) field service engineer (fse) attempted to reset the stm, at which point it unexpectedly disengaged and began to fall.The fse intervened to prevent the module from dropping, resulting in a muscle strain to the left shoulder and upper back.The injury was not immediately apparent at the time of the incident but progressively worsened during the fse¿s drive home.The fse reported the incident to their supervisor and contacted the medical call center to seek medical evaluation and guidance.
Additional Manufacturer Narrative
The fse indicated that dust and debris buildup along the guide rails likely contributed to the rollers being stuck.The fse sought medical attention the following morning (b)(6) 2026) and was diagnosed with lumbar spine strain, strain of the left shoulder, and strain of the thoracic spine.The fse has been on light duty restrictions and undergoing physical therapy.Bec internal identifier - (b)(4).

• Brand Name: UNICEL DXH SMS COULTER CELLULAR ANALYSIS SYSTEM
• Common Device Name: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTEER INC.; 11800 sw 147th ave.; miami FL 33196
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318
• MDR Report Key: 24574846
• Report Number: 1061932-2026-00008
• Device Sequence Number: 10334807
• Product Code: GKZ
• UDI-Device Identifier: 15099590192679
• UDI-Public: (01)15099590192679(11)111209
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2026

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 UNICEL? DXH SLIDEMAKER STAINER
• Device Catalogue Number: 775222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2011
• 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