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	05/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported obtaining low patient results for glucose, albumin, and magnesium on their dxc 700 au clinical chemistry analyzer.The results were released outside the laboratory.The customer indicated a change in patient management, where the patient was started on magnesium medication, which was then discontinued after corrected results were amended.Beckman coulter contacted the customer for more details, but they declined to provide additional patient information.However, they confirmed the patient was not harmed.There was no report of death associated with this event.The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
The beckman field service engineer (fse) evaluated the dxc 700 au clinical chemistry analyzer and replaced the degasser and tightened the reagent r2 syringe case to resolve the issue.The fse verified quality control was acceptable, and the analyzer was back to normal operation.Section a2, a3, a4, and a5: information not provided by customer.Beckman coulter internal identifier is (b)(4).

• 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: 25593517
• Report Number: 9612296-2026-00243
• Device Sequence Number: 20258766
• Product Code: JJE
• UDI-Device Identifier: 14987666542545
• UDI-Public: (01)14987666542545(11)220118
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/17/2026

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: 05/22/2026
• Initial Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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