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	01/16/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer reported falsely decreased alinity c co2 generated from alinity c processing module and provided the following data for a 34-year-old male patient on (b)(6) 2026: customer bicarb/co2 reference interval - 22 to 32 mmol/l.Sample (b)(6) alinity bicarbonate =12 mmol/l (b)(6), 13 mmol/l (b)(6) & 13 mmol/l (b)(6) , radiometer abl 800= 25.4mmol/l, lipaemic index=2.94, triglyceride= 31.64mmol/l.For sample (b)(6) (same patient different sample) alinity bicarbonate= 13mmol/l (b)(6), abl 800= 26.6 mmol/l, lipaemic index=3.40.Patient information: icu admitting diagnosis of pyrexia of unknown origin the customer reported that they amended the co2 results and it was reported that there was no known adverse impact to the patient.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely decreased alinity c co2 generated from alinity c processing module and provided the following data for a 34-year-old male patient on (b)(6) 2026: customer bicarb/co2 reference interval - 22 to 32 mmol/l.Sample (b)(6) alinity bicarbonate =12 mmol/l (b)(6), 13 mmol/l (b)(6) & 13 mmol/l (b)(6).Radiometer abl 800= 25.4mmol/l lipaemic index=2.94 triglyceride= 31.64mmol/l.For sample (b)(6) (same patient different sample) alinity bicarbonate= 13mmol/l (b)(6) abl 800= 26.6 mmol/l lipaemic index=3.40.Patient information: icu admitting diagnosis of pyrexia of unknown origin the customer reported that they amended the co2 results and it was reported that there was no known adverse impact to the patient.There was no reported impact to patient management.
Additional Manufacturer Narrative
Additional information in d10 - concomitant product data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending for the alinity c carbon dioxide reagent did not identify any trends related to the complaint issue.Additionally, no trends were identified for the complaint list and complaint lot number.Device history record review did not identify any non-conformances, potential non-conformances or deviations associated with the complaint lot number.The overall performance of the alinity c carbon dioxide assay in the field was reviewed using data gathered from customers worldwide.The patient median result for lot 68444uq06 is within the established control limits, no unusual reagent lot performance was identified for the lot, indicating that the lot is performing acceptably in the field.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity c carbon dioxide reagent lot 68444uq06 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: 24269601
• Report Number: 3002809144-2026-00024
• Device Sequence Number: 10021227
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)260731(10)68444UQ06
• 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): 04/03/2026

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: 07/31/2026
• Device Catalogue Number: 07P72-20
• Device Lot Number: 68444UQ06
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 04/03/2026
• 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); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Age: 34 YR
• Patient Sex: Male