MAUDE Adverse Event Report: BECKMAN COULTER, INC DXC 700 AU CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the issue and observed the drain system was functional.As a recommendation to improve the flow, the fse installed anti-foam pump.Following the installation, fse observed no foam overflowing from the drain.The system returned to normal operation.The probable cause for this event was an accidental injury.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported on their dxc 700 analyzer where the waste drain generated foam and overflowed, making the floor slippery.As a result, a laboratory operator slipped, fell and sustained injuries to their back and leg.At the time of the incident, the operator was wearing personal protective equipment (ppe).The operator sought urgent care and began physical therapy.It is unknown if medication was prescribed.The operator returned to work on (b)(6) 2026, with work restrictions.No additional details were provided.There was no report of death associated with this event.

• Brand Name: DXC 700 AU CLINICAL CHEMISTRY ANALYZER
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER, INC; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho sunto-gun; schizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25250169
• Report Number: 9612296-2026-00218
• Device Sequence Number: 10534481
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)250624
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K161837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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: DXC 700 AU-10E CHEMISTRY ANALYZER DXC 700 AU WITH ISE
• Device Catalogue Number: B86444
• Device Lot Number: N/A
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown