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

Catalog Number	07P72-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated co2 results generated on the alinity c processing module on multiple patients.Example results provided: pt 1 initial result= 31 rerun other instruments = 25.Pt 2 initial result= 36 rerun other instruments = 26.Pt 3 initial result= 31 rerun other instruments = 24.Customer normal range (22-28 meq/l).No impact to patient management was reported.
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 reported falsely elevated co2 results generated on the alinity c processing module on multiple patients.Example results provided: pt 1 initial result= 31 rerun other instruments = 25, pt 2 initial result= 36 rerun other instruments = 26, pt 3 initial result= 31 rerun other instruments = 24, customer normal range (22-28 meq/l).No impact to patient management was reported.
Additional Manufacturer Narrative
A review of tickets determined that there is normal complaint activity for lot 68432uq05.Trending review determined no trends for elevated results for the product.The issue appears to be sample specific since samples were rerun using the same lot of reagent and generated acceptable results.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of carbon dioxide (co2) reagent (ln 7p72-20) lot 68432uq05, 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: 23449926
• Report Number: 3002809144-2025-00349
• Device Sequence Number: 18382750
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)260630(10)68432UQ05
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 11/25/2025

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: 06/30/2026
• Device Catalogue Number: 07P72-20
• Device Lot Number: 68432UQ05
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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