MAUDE Adverse Event Report: BECKMAN COULTER, INC. BICARBONATE 4 X 50 ML; ENZYMATIC, CARBON-DIOXIDE

Model Number	BICARBONATE 4 X 50 ML
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
This event was initially reported under mdr 9612296-2025-00950.Following a review completed on february 20, 2026, it was determined that this event should be reported under the reagent, rather than the analyzer.On (b)(6) 2025, it was reported by the customer that there were erroneously high carbon dioxide (co2) patient results while using the dxc 700 au chemistry analyzer.The customer indicated that the co2 results from the arterial blood gas were "significantly different" than the total co2 measured on the beckman coulter dxc 700 au analyzer.The customer also indicated that the patient was "very sick" with multiple morbidities.Per the customer, the patient was suspected to have high lactate dehydrogenase (ldh) and lactate (lac) results.The customer reported a possible delay in changing the dosage of continuous renal replacement therapy (crrt) due to the erroneously high co2 results.The customer reported the patient passed away.
Additional Manufacturer Narrative
Service was not requested.Beckman coulter gpts (global product technical support) was consulted and indicated that the co2 instructions for use (ifu) does not list ldh or lactate as a possible interferent for co2.Based on the available information, the probable cause is unknown.There is no evidence of a system or reagent malfunction.The investigation is in progress.Per medical review, the reported death is not attributed to a bec instrument or reagent.There was a delay in change in ccrt because serum co2 was falsely high on (b)(6).Per the customer, ¿three days later¿ the patient passed away.This case is being reported as a serious injury because there was a reported delay in change of treatment, specifically a change in dose in crrt due to the patient¿s serum co2 being falsely high.There was a report of a patient death, however, there is no information that reasonably suggests that the falsely high results may have caused or contributed to the death.Internal and external medical reviews of the case indicated that the patient was severely ill and had several comorbidities that likely impacted the patient¿s outcome.Section a2, a3, a4, a5 and a6: information not provided by customer.The beckman coulter internal identifier is (b)(4).

• Brand Name: BICARBONATE 4 X 50 ML
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): BECKMAN COULTER, INC.; 250 s. kraemer blvd.; brea 92821
• Manufacturer (Section G): BECKMAN COULTER IRELAND; lismeehan; o'callaghan's mills, co clare ; EI
• Manufacturer Contact: shama agtey ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9524916938
• MDR Report Key: 24635522
• Report Number: 9680746-2026-00001
• Device Sequence Number: 21130285
• Product Code: KHS
• UDI-Device Identifier: 15099590020187
• UDI-Public: (01)15099590020187(17)260301(11)250201(10)2707
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K131546
• Number of Events Summarized: 1
• Summary Report (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): 03/18/2026

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 Expiration Date: 03/01/2026
• Device Model Number: BICARBONATE 4 X 50 ML
• Device Catalogue Number: OSR6237
• Device Lot Number: 2707
• 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: 02/20/2026
• Initial Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• 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