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	04/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not completed as returns were not available.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 66642uq07.Device history review did not identify any non-conformance's or deviations with the complaint lot number and complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity c carbon dioxide reagent was identified.
Event or Problem Description
The customer observed falsely depressed alinity c co2 results for two samples.The following results were provided: sid (b)(6) alinity c co2 result 20, cobas result 22.4, siemens result 22.1 sid (b)(6) alinity c co2 result 21, cobas result 22.7, siemens result 22.3 no impact to patient management was 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: 22073556
• Report Number: 3002809144-2025-00164
• Device Sequence Number: 15628887
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)250831(10)66642UQ07
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 05/22/2025

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: 08/31/2025
• Device Catalogue Number: 07P72-20
• Device Lot Number: 66642UQ07
• 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: 05/02/2025
• Initial Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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: ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Sex: Unknown