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 AU680 WITH ISE
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Beckman coulter field service engineer (fse) confirmed that the probable cause was identified as a malfunctioning sample level detection board.The fse replaced the sample level detection pcb (printed circuit board) and confirmed the sample probe alignment, and this resolved the issue.Section a2, a4 and a5: information not provided by the customer.The beckman coulter internal identifier is (b)(4).
Event or Problem Description
The customer reported low patient results on multiple analytes with g flags including ast (aspartate aminotransferase), alt (alanine aminotransferase), glu (glucose), na (sodium) k (potassium) and cl (chloride) on their au680 chemistry analyzer part number b96696 and instrument serial number (b)(6).There was no report of change to treatment, injury, death, or delay/change in treatment associated with this event.The customer did not provide patient demographics.

• 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 INC.; 454-32 higashino; nagaizumi-cho sunto-gun; shizuoka JP-NO TA 4; JA JP-NOTA 41
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24083344
• Report Number: 9612296-2026-00015
• Device Sequence Number: 17618540
• Product Code: JJE
• UDI-Device Identifier: 14987666543009
• UDI-Public: (01)14987666543009(11)140618
• Combination Product (Y/N): N
• Initial Reporter Country: KN
• PMA/510(K) Number: K961274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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 AU680 WITH ISE
• Device Catalogue Number: B96696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2014
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown