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

Catalog Number	03L80-32
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for section a1 patient identifier: sid (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 depressed carbon dioxide results generated on the architect c16000 processing module for one patient.The following data was provided: on (b)(6) 2025, sid (b)(6): initial result = 9.2 mmol/l, repeat = 9.9 mmol/l, vitros result = 18 mmol/l, radiometer result = 23 mmol/l.The customer indicated the sample is lipemic.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely depressed carbon dioxide results generated on the architect c16000 processing module for one patient.The following data was provided: on (b)(6) 2025, sid: (b)(6): initial result = 9.2 mmol/l, repeat = 9.9 mmol/l, vitros result = 18 mmol/l, radiometer result = 23 mmol/l.The customer indicated the sample is lipemic.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the carbon dioxide assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot: 66349uq05.Device history review did not identify any nonconformance's or deviations associated with lot: 66349uq05.Labeling was reviewed and found to adequately address the issue.Based on our investigation, no systemic issue or deficiency with the carbon dioxide reagent was identified.

• 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: 22553539
• Report Number: 3002809144-2025-00236
• Device Sequence Number: 15864939
• Product Code: KHS
• UDI-Device Identifier: 00380740161538
• UDI-Public: (01)00380740161538(17)250630(10)66349UQ05
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/29/2025

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: 06/30/2025
• Device Catalogue Number: 03L80-32
• Device Lot Number: 66349UQ05
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC C16K PRC MOD, 03L77-01, (B)(6).; ARC C16K PRC MOD, 03L77-01, (B)(6).
• Patient Sex: Unknown