MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	07P72-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinity c carbon dioxide results when compared with blood gas results for a 79-year-old male patient sample.The following data was provided (customer¿s reference range 22 - 32 mmol/l): sample id (b)(6), on (b)(6) 2025, initial result = 2.0 mmol/l, repeat result = 2.2 mmol/l, on (b)(6) 2025 repeat result = 1.7 mmol/l.Venous blood gas result on radiometer platform = 29.0 mmol/l (reference range 22-28 mmol/l).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.Complete entry section a1 - patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed alinity c carbon dioxide results when compared with blood gas results for a 79-year-old male patient sample.The following data was provided (customer¿s reference range 22 - 32 mmol/l): sample id (b)(6), (b)(6) 2025 initial result = 2.0 mmol/l, repeat result = 2.2 mmol/l, (b)(6) 2025 repeat result = 1.7 mmol/l.Venous blood gas result on radiometer platform = 29.0 mmol/l (reference range 22-28 mmol/l) no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the alinity c carbon dioxide assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 67723uq01.Device history record review did not identify any nonconformances, or deviations associated with the complaint lot number.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c carbon dioxide reagent, lot 67723uq01, was identified.

• Brand Name: ALINITY C CARBON DIOXIDE REAGENT KIT
• 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: 23229711
• Report Number: 3002809144-2025-00313
• Device Sequence Number: 9648885
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)260228(10)67723UQ01
• 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): 12/17/2025

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: 02/28/2026
• Device Catalogue Number: 07P72-20
• Device Lot Number: 67723UQ01
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Age: 79 YR
• Patient Sex: Male