MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CARBON DIOXIDE; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	03L80-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: sample ids = (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely decreased co2/bicarb generated from architect when compared to a venous blood gas result.The customer provided the following data: on (b)(6) 2025, a patient that was reportedly extremely lipemic (no value provided) had a co2 of 8.9 mmol/l (sample id: (b)(6)).The patient's physician questioned the result since it didn't match the patient's clinical presentation.Another sample was obtained (sample id: (b)(6)) and generated a result of 8.8 mmol/l.1:2 dilution testing generated resutls of < 10.1 and < 10.1 mmol/l (customer reference range: 20-29 mmol/l).A venous blood gas was obtained and showed a pco2 of 38 mmhg (reportedly normal per customer).It was confirmed that the patient did not receive any treatment related to the falsely decreased co2 result.There was no reported impact to patient management.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect carbon dioxide (co2) reagent, lot 68323uq05.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history record review did not identify any non-conformances or potential non-conformances associated with the complaint lot.Troubleshooting was performed by the customer by running a venous sample on a blood gas machine that showed a normal co2 result.Additionally, quality controls were acceptable at the time of the incident.Labeling was reviewed and adequately addressed the issue.Based on the investigation, no systemic issue or deficiency of the architect co2 reagent, lot 68323uq05 was identified.
Event or Problem Description
The customer observed falsely decreased co2/bicarb generated from architect when compared to a venous blood gas result.The customer provided the following data: on (b)(6) 2025, a patient that was reportedly extremely lipemic (no value provided) had a co2 of 8.9 mmol/l (sample id (b)(6).The patient's physician questioned the result since it didn't match the patient's clinical presentation.Another sample was obtained (sample id (b)(6) and generated a result of 8.8 mmol/l.1:2 dilution testing generated resutls of < 10.1 and < 10.1 mmol/l (customer reference range: 20-29 mmol/l).A venous blood gas was obtained and showed a pco2 of 38 mmhg (reportedly normal per customer).It was confirmed that the patient did not receive any treatment related to the falsely decreased co2 result.There was no reported impact to patient management.

• Brand Name: ARCHITECT CARBON DIOXIDE
• Common Device Name: ENZYMATIC, CARBON-DIOXIDE
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23848081
• Report Number: 3002809144-2025-00395
• Device Sequence Number: 9607335
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: (01)00380740161521(17)260630(10)68323UQ05
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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 Expiration Date: 06/30/2026
• Device Catalogue Number: 03L80-22
• Device Lot Number: 68323UQ05
• 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: 12/03/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C4000 INTGR, 02P24-40, C403338; ARC C4000 INTGR, 02P24-40, C403338
• Patient Sex: Unknown