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

Model Number	DXC 700 AU-10E CHEMISTRY ANALYZER WITH ISE
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched and provided onsite support.The probable cause identified was a faulty sample transfer unit.The fse replaced sample transfer unit to resolve the issue.The fse also aligned sample transfer unit, verified gas pressure value (gpv) at 14.5 psi, completed 260 primes, verified dead volume adjustment at track sample aspiration position and adjusted rotation and height.The customer was satisfied.No further action is required.Section a2, a4 & a5: the information was not provided.The beckman coulter internal identifier is case (b)(4).
Event or Problem Description
The customer reported obtaining ongoing erroneous zero results with ¿g¿ flags for patient samples on their dxc 700 au clinical chemistry analyzer (product number b86444, serial number (b)(6).Upon follow-up, the customer specified all assays were impacted.There was no erroneous patient result reported outside of the laboratory.There was no injury, death, or delay/change in treatment associated with this event.The customer did not provide patient data and/or patient demographics.Note: per dxc 700 au chemistry analyzer instructions for use (ifu) guide b71495af: o flag ¿g¿: result is lower than the analytical measuring range.O flag ¿/¿: test pending or not analyzed.O flag ¿?¿: unable to calculate a result.

• Brand Name: DXC 700 AU ISE
• 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 MISHIMA K. K.; 454-32 higashino; nagaizumi-cho sunto-gun; shizuoka 411-0 931; JA 411-0931
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 25204175
• Report Number: 9612296-2026-00211
• Device Sequence Number: 10010126
• 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
• Serviced by Third Party (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): 05/18/2026

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 WITH ISE
• Device Catalogue Number: B86444
• 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: 04/24/2026
• Initial Report FDA Received Date: 05/18/2026
• 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