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	06/25/2025
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.
Event or Problem Description
The customer reported low anion gap (< 3) and upon further review noted decreased results for alinity c co2 generated from alinity c processing module.The customer provided the following data: sid: (b)(6) co2 was 23 and repeat was 22 (sn: (b)(6).Repeat on another analyzer (sn: (b)(6) and the result was 21.Patient¿s result from yesterday was 24.Customer reference range is for co2 is 22-31 mmol/l.Customer also repeated sample (b)(6) and co2 was 22 (sn: (b)(6) and repeat result was 21 (sn: (b)(6).There was no reported impact to patient management.
Event or Problem Description
The customer reported low anion gap (< 3) and upon further review noted decreased results for alinity c co2 generated from alinity c processing module.The customer provided the following data: sid (b)(6) co2 was 23 and repeat was 22 (sn:(b)(6)).Repeat on another analyzer (sn: (b)(6)) and the result was 21.Patient¿s result from yesterday was 24.Customer reference range is for co2 is 22-31 mmol/l customer also repeated sample (b)(6) and co2 was 22 (sn: (b)(6)) and repeat result was 21 (sn: (b)(6)).There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, trending review, labeling review, and device history record review and field data review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review for the complaint lot did not identify any issues.A review of tracking and trending did not identify an increase in complaints for the alinity c carbon dioxide and complaint lot for the complaint issue.The overall performance of the alinity c carbon dioxide reagent reviewed using field data from customers.The review of field data for the complaint lot determined the median values are within the established limits and concluded that the lot generated the expected results.Labeling was reviewed and was found to address the customer reported event.Based on the available information, no systemic issue or deficiency was identified for the alinity c carbon dioxide reagent lot 67723uq01.

• 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: 22549157
• Report Number: 3002809144-2025-00235
• Device Sequence Number: 19838976
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)260228(10)67723UQ01
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2025

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: 06/25/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/19/2025
• 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)
• Patient Sex: Unknown