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-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to evaluate the dxc 700 au clinical chemistry analyzer.The fse verified alignments and no issues were found.The fse was unable to identify any system malfunction.The cause of false results is unknown.The fse suspects that the cause may have been patient sample itself due low sample volume.The customer had drawn a new sample and obtained normal results.No hardware parts were replaced.The cause could not be determined with the available information.There is insufficient evidence to suggest that the system or reagent malfunction.Section a2, a4, and a5: information not provided by customer.Section e1 initial reporter phone number is (b)(6).The beckman coulter identifier is case (b)(4).
Event or Problem Description
The customer reported that they obtained erroneously low patient results with (g) flag on a four-month-old baby patient sample for triglycerides (trig), phosphorous (phos), urea nitrogen (bun), and protein on their dxc700au clinical chemistry analyzer.The erroneous patient results were reported out of the laboratory.There was a report of change in patient treatment, the patient received intravenous (iv) infusion treatment due to false results.The patient sample was redrawn, and treatment stopped after receiving new results which were considered correct by the customer.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
• Manufacturer (Section G): BECKMAN COULTER MISIMA 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: 24649541
• Report Number: 9612296-2026-00124
• Device Sequence Number: 10008688
• Product Code: JJE
• UDI-Device Identifier: 14987666542514
• UDI-Public: (01)14987666542514(11)180405
• Combination Product (Y/N): N
• PMA/510(K) Number: K161837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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-10DE, CHEMISTRY ANALYZER DXC 700 AU FOR DIRECT TR
• Device Catalogue Number: B86446
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2018
• 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
• Patient Sex: Unknown