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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the dxc 700 au clinical chemistry analyzer and identified multiple hardware malfunctions.The fse found bubbles in tubing due to a faulty degasser.The fse also found reagent and sample probes were misaligned and a worn reagent syringe.The fse replaced the degasser unit, reagent probe, sample probe and reagent syringe to resolve the issue.Following the repairs, the fse performed calibration and quality control with passing results.The fse verified the analyzer returned to normal operation.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is case: (b)(4).
Event or Problem Description
The customer reported obtaining low patient results with a ¿g¿ flag for multiple chemistries including sodium (na), potassium (k), chloride (cl), bicarbonate (co2), glucose (glu), total protein (tp), total bilirubin (tbil), albumin (alb), creatinine (creat), calcium (ca), blood urea nitrogen (bun), aspartate aminotransferase (ast), alkaline phosphatase (alp), and alanine aminotransferase (alt) involving their dxc 700 au clinical chemistry analyzer.The low results were not reported outside the laboratory.There was no report of change to treatment, injury, or death associated with this event.The customer did not provide patient demographics but shared only the initial results for two patients.

• 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: 25224197
• Report Number: 9612296-2026-00214
• Device Sequence Number: 9801685
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)250714
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/22/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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
• Patient Sex: Unknown