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	04/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed discrepant carbon dioxide (co2) results generated from alinity c processing module for several patients during (b)(6) 2025.The results provided were: the unit is mmol/l.(b)(6) initial=25.2 /repeated=30.0.(b)(6) initial=18.2 /repeated=26.3.(b)(6) initial=19.2 /repeated=19.3 and 24.6.(b)(6) initial=19.4 /repeated=19.7 and 27.8.(b)(6) initial=18.4 /repeated=22.8.(b)(6) initial=17.4 /repeated=22.5.(b)(6) initial=16.2 /repeated=17.0 and 23.5.(b)(6) initial=17.1 /repeated=17.5 and 28.3.(b)(6) initial=19.4 /repeated=22.4.(b)(6) initial=19.2 /repeated=27.5.(b)(6) initial=16.7 /repeated=18.0 and 24.1.(b)(6) initial=17.1 /repeated=22.7.(b)(6) initial=21.6 /repeated=30.5.(b)(6) initial=25.4 /repeated=30.2.(b)(6) initial=24.7 /repeated=30.9.(b)(6) initial=26.4 /repeated=31.3.(b)(6) initial=27.6 /repeated=29.9.(b)(6) initial=24.3 /repeated=30.1.(b)(6) initial=27.0 /repeated=32.3.(b)(6) initial=26.6 /repeated=33.1.On (b)(6) 2025 (b)(6) initial=29.7 /repeated=25.6.On (b)(6) 2025 (b)(6) initial=29.7 /repeated=24.9.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint evaluation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, field data and device history record review of alinity c carbon dioxide reagent lot 66642uq07.Return testing was not completed as returns were not available.Review of all the information provided by the customer was reviewed.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.Historical performance of the alinity c carbon dioxide reagents in the field was reviewed using data gathered via abbottlink from customers worldwide.The number of standard deviations to cut-off for the negative population and the patient median values obtained with the complaint lot(s) are within established limits and thus comparable to the historical lot performance, which confirms no systemic issue for the lot(s).Device history record review did not identify any non-conformances or deviations with the complaint lots and complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity c carbon dioxide reagent lot 66642uq07.
Event or Problem Description
The customer observed discrepant carbon dioxide (co2) results generated from alinity c processing module for several patients during 12apr through 23apr2025.The results provided were: the unit is mmol/l.Sid (b)(6) initial=25.2 /repeated=30.0.Sid (b)(6) initial=18.2 /repeated=26.3.Sid (b)(6) initial=19.2 /repeated=19.3 and 24.6.Sid (b)(6) initial=19.4 /repeated=19.7 and 27.8.Sid (b)(6) initial=18.4 /repeated=22.8.Sid (b)(6) initial=17.4 /repeated=22.5.Sid (b)(6) initial=16.2 /repeated=17.0 and 23.5.Sid (b)(6) initial=17.1 /repeated=17.5 and 28.3.Sid (b)(6) initial=19.4 /repeated=22.4.Sid (b)(6) initial=19.2 /repeated=27.5.Sid (b)(6) initial=16.7 /repeated=18.0 and 24.1.Sid (b)(6) initial=17.1 /repeated=22.7.Sid (b)(6) initial=21.6 /repeated=30.5.Sid (b)(6) initial=25.4 /repeated=30.2.Sid (b)(6) initial=24.7 /repeated=30.9.Sid (b)(6) initial=26.4 /repeated=31.3.Sid (b)(6) initial=27.6 /repeated=29.9.Sid (b)(6) initial=24.3 /repeated=30.1.Sid (b)(6) initial=27.0 /repeated=32.3.Sid (b)(6) initial=26.6 /repeated=33.1.On (b)(6) 2025 sid (b)(6) initial=29.7 /repeated=25.6.On (b)(6) 2025 sid (b)(6) initial=29.7 /repeated=24.9.There was no reported impact to patient management.

• 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: 21962595
• Report Number: 3002809144-2025-00150
• Device Sequence Number: 7151706
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)250831(10)66642UQ07
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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
• Usage of Device: Unknown
• 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