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

Catalog Number	07P72-20
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed inconsistent alinity c co2 results when processing on the alinity c processing module.On (b)(6) 2025 samples were repeated and results were amended.The customer uses reference range: 21 ¿ 30 mmol/l.Sid (b)(6) tested 35, 24, 29.Sid (b)(6) tested 31, 19, 24.Sid (b)(6) tested 32, 20, 26.Sid (b)(6) tested 31, 18, 24.Sid (b)(6) tested 37, 24.Sid (b)(6) tested 39, 24.Sid (b)(6) tested 35, 24.Sid (b)(6) tested 39, 22.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a patient information: patient identifier multiple is (b)(6).No additional patient information was provided.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
After customer recalibrating the assay, the qc results fell within range, and the issue with the discrepant carbon dioxide results was resolved.The investigation showed, the ticket trending review of complaint data for the complaint list number does not identify any increase in complaint activity.A lot number search was not performed, as the lot number is unknown.The labeling review concludes that the issue is adequately addressed.A device history review did not identify any non-conformances associated with the complaint issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity c carbon dioxide reagent identified in this complaint.
Event or Problem Description
The customer observed inconsistent alinity c co2 results when processing on the alinity c processing module.On (b)(6) 2025 samples were repeated and results were amended.The customer uses reference range: 21 ¿ 30 mmol/l.Sid (b)(6) tested 35, 24, 29.Sid (b)(6) tested 31, 19, 24.Sid (b)(6) tested 32, 20, 26.Sid (b)(6) tested 31, 18, 24.Sid (b)(6) tested 37, 24.Sid (b)(6) tested 39, 24.Sid (b)(6) tested 35, 24.Sid (b)(6) tested 39, 22.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: 23237830
• Report Number: 3002809144-2025-00315
• Device Sequence Number: 13216727
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/17/2025

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 Catalogue Number: 07P72-20
• 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: 09/12/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/07/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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