MAUDE Adverse Event Report: BECKMAN COULTER INC. AU5800-20 CHEMISTRY ANALYZER AUTOMATION READY; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	AU5800-20 CHEMISTRY ANALYZER AU5800 AUTOMATION READY
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The beckman coulter field service engineer (fse) was dispatched to the customer site.The probable cause was identified as multiple malfunctioning instrument components; however, it is unknown which component exactly contributed to the reported failure.Issue was resolved by replacement of multiple parts including sample valves, inner r2 driver, inner sample syringe and case, inner wash case, inner r2 syringe case and syringe.The fse verified instrument performance.The customer was satisfied.No further action is required.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 generation of erroneous patient results for blood urea nitrogen (bun) and glucose (glu) on their au5800 clinical chemistry analyzer (pn b96693; sn (b)(6)).The erroneous patient results were not reported out of laboratory.There were no injuries, deaths, or delays/changes in treatment associated with this event.The customer did not provide patient data and patient demographics.

• Brand Name: AU5800-20 CHEMISTRY ANALYZER AUTOMATION READY
• 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: 25128886
• Report Number: 9612296-2026-00196
• Device Sequence Number: 13446161
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• UDI-Public: (01)14987666543023(11)200224
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112412
• 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): 05/08/2026

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: AU5800-20 CHEMISTRY ANALYZER AU5800 AUTOMATION READY
• 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: 04/14/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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