MAUDE Adverse Event Report: ABBOTT GMBH 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	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased carbon dioxide results processed on the architect c16000 processing module.The customer repeated the sample and the results are higher.The customer provided the following data for one patient: initial result = 8.6438 mmol/l repeat result = 24.7098 mmol/l.Normal reference range is 22-29 no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely decreased co2 results included a review of data and information provided by the customer, labeling review, search for similar complaints, ticket trending review, and device history record review.Return testing was not completed as returns were not available.A ticket search by the lot number did not identify an increase in complaint activity related to the issue under review.Trending review by the list number did not identify an increase in complaint activity related to the issue under review.Manufacturing documentation (device history record) for the likely cause did not identify any issues associated with the complaint issue.This indicates the assay is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no deficiency was identified.
Event or Problem Description
The customer observed falsely decreased carbon dioxide results processed on the architect c16000 processing module.The customer repeated the sample and the results are higher.The customer provided the following data for one patient: initial result = 8.6438 mmol/l repeat result = 24.7098 mmol/l.Normal reference range is 22-29.No impact to patient management was reported.

• Brand Name: 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: 22299500
• Report Number: 3002809144-2025-00196
• Device Sequence Number: 15750441
• Product Code: KHS
• UDI-Device Identifier: 00380740161521
• UDI-Public: (01)00380740161521(17)251231(10)67325UQ11
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060295
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

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: 12/31/2025
• Device Catalogue Number: 03L80-22
• Device Lot Number: 67325UQ11
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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