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	10/11/2024
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed a falsely depressed alinity c carbon dioxide for one patient with a history of plasma cell dyscrasia and igg lambda and oligoclonal immunoglobulins.The patient had historical normal co2 results starting in 2002.In 2019, the patient had an epp performed which identified a small discreet abnormal band.It was also noted beginning in 2019 that the co2 values were lower and by 2021 the results generated were <20 mmol/l.The patient sample generated the low results on the alinity, but when run on a roche analyzer and a blood gas analyzer, the co2 results were normal.The following results were provided: on (b)(6) 2024, sid (b)(6), initial co2 result (bowen hills facility) = 10 mmol/l.On (b)(6) 2025, sid (b)(6), initial co2 result (bowen hills facility) = 6.36 mmol/l; blood gas result= 24 mmol/l (reported).On (b)(6) 2025, sid (b)(6), initial co2 result (lismore facility) = 7 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
Update to section b5 - describe event or problem to include addition patient information.The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.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, however, a search for similar complaints could not be performed as the complaint lot number is unknown.A device history record review in did not identify any nonconformances related to the complaint issue.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the alinity c carbon dioxide lot unknown was identified.
Event or Problem Description
The customer observed a falsely depressed alinity c carbon dioxide for one patient with a history of plasma cell dyscrasia and igg lambda and oligoclonal immunoglobulins.The patient had historical normal co2 results starting in 2002.In 2019, the patient had an epp performed which identified a small discreet abnormal band.It was also noted beginning in 2019 that the co2 values were lower and by 2021 the results generated were <20 mmol/l.The patient sample generated the low results on the alinity, but when run on a roche analyzer and a blood gas analyzer, the co2 results were normal.The following results were provided: (b)(6) 2024, sid (b)(6), initial co2 result (bowen hills facility)= 10 mmol/l.(b)(6) 2025, sid (b)(6), initial co2 result (bowen hills facility)= 6.36 mmol/l; blood gas result= 24 mmol/l (reported).(b)(6) 2025, sid (b)(6), initial co2 result (lismore facility)= 7 mmol/l.Additional information was provided on 17apr2025.The patient had a history of diabetes, essential hypertension, presumed autoimmune hypothyroidism, hypercholesterolemia, diverticulitis and mgus.The following historical results were provided: (b)(6) 2019, co2= 22 mmol/l; (b)(6) 2020, co2= 22 mmol/l; (b)(6) 2020, co2= 20 mmol/l; (b)(6) 2021, co2= 17 mmol/l; (b)(6) 2023= 11 mmol/l; (b)(6) 2024 <5 mmol/l; (b)(6) 2024= 7 mmol/l; (b)(6) 2024= 7 mmol/l; (b)(6) 2024= 5 mmol/l; (b)(6) 2024= 5 mmol/l; (b)(6) 2024= 6 mmol/l; (b)(6) 2024 <5 mmol/l; (b)(6) 2024= 6 mmol/l from the co2 results provided, in (b)(6) 2024 the patient received bicarb treatment, but the patient was not responding to the treatment ((b)(6) 2023, bicarbonate was 8 mmol/l, in (b)(6) 2023 (after treatment commenced), bicarb was 10 mmol/l).A blood gas was drawn and the results did not align with the previous results provided.On (b)(6) 2025, the patient had another blood drawn and the co2 results were <5 mmol/l at the bowen hills facility.Repeat result on blood gas analyzer= 15 mmol/l.There was no impact to patient management 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: 21784821
• Report Number: 3002809144-2025-00123
• Device Sequence Number: 18311737
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 03/18/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/07/2025
• 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) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6) ; ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown