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	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete 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 a falsely depressed alinity c carbon dioxide for one patient.The following results were provided (reference range 22 ¿ 32 mmol/l): (b)(6) 2025, sid (b)(6), initial co2 result ((b)(6)) = 6.8 mmol/l; repeat result= 6.8 mmol/l; repeat result ((b)(6)) = 4.1 mmol/l; radiometer co2 result= 20 mmol/l (released result); lipemia index= 1.3; triglyceride= 27 mmol/l additional results were provided: qep (serum protein electrophoresis) and sflc (serum free light chain) were normal.Additional samples were collected with the following results: sid (b)(6), initial co2 result= 15 mmol/l; radiometer co2= 17 mmol/l, lipemia index= 0.83, triglycerides= 21.9.(b)(6) 2025, sid (b)(6), initial co2 result= 21 mmol/l; radiometer co2 result = 25 mmol/l; lipemia index= 0.29.(b)(6) 2025, sid (b)(6), initial co2 result= 21 mmol/l; radiometer co2 result = 23 mmol/l; lipemia index= 0.11; triglycerides= 4.9.(b)(6) 2025, sid (b)(6), initial co2 result= 23 mmol/l; radiometer co2 result = 25 mmol/l; lipemia index= 0.38; triglycerides= 5.8 there was no impact to patient management 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, device history record review, field data review and labeling 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 an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 67723uq01.The device history record review found no issue related to the current complaint for lot number 67723uq01.The overall performance of the alinity c carbon dioxide reagents in the field was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for the lot numbers in the field for lot number 67723uq01 is within the established control limits.Therefore, no unusual reagent performance was identified.Review of labeling found adequate information regarding the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity c carbon dioxide reagent lot 67723uq01 was identified.
Event or Problem Description
The customer observed a falsely depressed alinity c carbon dioxide for one patient.The following results were provided (reference range 22 ¿ 32 mmol/l): on (b)(6) 2025, sid (b)(6), initial co2 result(b)(6) = 6.8 mmol/l; repeat result= 6.8 mmol/l; repeat result (b)(6) = 4.1 mmol/l; radiometer co2 result= 20 mmol/l (released result); lipemia index= 1.3; triglyceride= 27 mmol/l.Additional results were provided: qep (serum protein electrophoresis) and sflc (serum free light chain) were normal.Additional samples were collected with the following results: sid (b)(6) , initial co2 result= 15 mmol/l; radiometer co2= 17 mmol/l, lipemia index= 0.83, triglycerides= 21.9.On (b)(6) 2025, sid (b)(6) , initial co2 result= 21 mmol/l; radiometer co2 result = 25 mmol/l; lipemia index= 0.29.On (b)(6) 2025, sid (b)(6), initial co2 result= 21 mmol/l; radiometer co2 result = 23 mmol/l; lipemia index= 0.11; triglycerides= 4.9.On (b)(6) 2025, sid (b)(6), initial co2 result= 23 mmol/l; radiometer co2 result = 25 mmol/l; lipemia index= 0.38; triglycerides= 5.8 there was no impact to patient management reported.

• 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: 23076319
• Report Number: 3002809144-2025-00296
• Device Sequence Number: 11923447
• 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): 11/05/2025

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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 11/05/2025
• 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 Sex: Unknown