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

Model Number	AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site to evaluate the dxc 700 au chemistry analyzer.The fse inspected the analyzer and found the sample probe misaligned, roller tubing flat and wash valve malfunctioning.The fse determined multiple hardware malfunctioned.The fse replaced the wash valve, roller tubing and realigned the probe to resolve the issue.The fse performed system verification successfully without issues.The system returned to normal operation.Section a2, a4, and a5: information not provided by customer.The beckman coulter identifier is case-(b)(4).
Event or Problem Description
The customer reported the au680 clinical chemistry generated false low patient results for multiple chemistries which includes sodium (na), potassium (k),chloride (cl), calcium (ca), blood urea nitrogen (bun), magnesium (mg), ethanol (etoh), aspartate aminotransferase (ast), glucose (glu), creatinine (crea), g-glutamyl transferase (ggt), total protein (tp), and carbon dioxide (co2) with "g" flags.Also, the customer reported.The customer also indicated that the issue was first observed during quality control (qc) testing and subsequently affected patient testing, the erroneous results were not reported outside the laboratory.The exact number of erroneous results is unknown as patient data was not available.Verbal example of results was provided for two (2) patients.There was no report of change to treatment, injury, or death associated to 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: 25374427
• Report Number: 9612296-2026-00232
• Device Sequence Number: 15772766
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)180928
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/03/2026

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
• Device Model Number: AU681-10E CHEMISTRY ANALYZER AU680 WITH ISE
• Device Catalogue Number: B96696
• 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: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2018
• 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