MAUDE Adverse Event Report: BECKMAN COULTER INC. AU681-10E CHEMISTRY ANALYZER WITH ISE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU681-10E CHEMISTRY ANALYZER WITH ISE
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported obtaining erroneously high sodium (na) patient results and stability error 3266 - ion selective electrode (ise) serum standard solution h generated on their au680 ise clinical chemistry analyzer (product number: b96696, serial number: (b)(6).There were no erroneously high na patient results released outside the laboratory.There was no injury, death, or delay/change in treatment associated with this event.The customer did not provide patient demographics.
Additional Manufacturer Narrative
A beckman coulter field service engineer (fse) was dispatched to the customer site.Upon further investigation, the fse determined ise calibration and selectivity failed.The probable cause identified was air in the buffer valve.The fse replaced multiple hardware parts per maintenance procedure that included ise tubing, ref valve and buffer valve to resolve the issue.The fse performed system verification successfully without further issues.The customer was satisfied.No further action is required.Section a2, a4 and a5: the information is not provided by the customer.The beckman coulter internal identifier is case-(b)(4).

• Brand Name: AU681-10E CHEMISTRY ANALYZER WITH 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: 25207228
• Report Number: 9612296-2026-00212
• Device Sequence Number: 13285899
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)171218
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 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: AU681-10E CHEMISTRY ANALYZER 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: 04/29/2026
• Initial Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2017
• 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