MAUDE Adverse Event Report: BECKMAN COULTER, INC AU5800 CHEMISTRY ANALYZER; 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	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On 25mar2026, the customer reported that a patient¿s enzymatic creatinine (crea) assay, tested on their au5800 chemistry analyzer, showed falsely high results.The customer attributed high results to igm paraprotein interference within enzymatic creatinine assay.When the sample was diluted and tested on different (non-beckman) analyzers, the results were lower.Due to high results being released outside the laboratory, the patient was recommended to a renal referral.The was no report of harm or death associated with this event.By 14apr2026, upon obtaining additional information, beckman coulter became aware that the patient was then sent to the emergency department (ed).The customer could not confirm whether the patient received any treatment while at the ed.The customer only indicated that the patient¿s chronic kidney disease stage was changed from stage 3b to 4.No further details were provided.The customer did not provide patient data or demographics.
Additional Manufacturer Narrative
Beckman coulter reviewed the enzymatic creatinine assay¿s instructions for use (ifu) clearly state under ¿interferences¿: ¿in very rare cases gammopathy, especially monoclonal igm ((waldenström¿s macroglobulinemia), may cause unreliable results.¿ the beckman field applications specialist (fas) adjusted the parameter settings to have a ¿z¿ flag to hold all high creatinine results for review to resolve the issue.The customer was satisfied and no further issues were reported.The analyzer returned to normal operation.Section a2, a3, a4, and a5: information not provided by customer.Section e1, initial reporter telephone number is (b)(6).Beckman coulter internal identifier is case-(b)(4).

• Brand Name: AU5800 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: 24971068
• Report Number: 9612296-2026-00177
• Device Sequence Number: 12009928
• Product Code: JJE
• UDI-Device Identifier: 14987666543023
• UDI-Public: (01)14987666543023(11)240215
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112412
• Number of Events Summarized: 1
• Summary Report (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): 04/23/2026

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: AU5800-20 CHEMISTRY ANALYZER AU5800 AUTOMATION READY
• Device Catalogue Number: B96698
• 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: 04/14/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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