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	11/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier complete entry = sample 1 and sample 2.All available patient information was included.Additional patient details are not available.The complaint investigation for falsely decreased patient results when using alinity c carbon dioxide, lot numbers 66500uq06 and 66642uq07, included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed, as returns were not available.A review of labeling and historical data was done, and both were adequate, with no increase in complaint activity.Manufacturing documentation for the likely cause lots was reviewed and did not identify any issues.Device history record review on lot numbers 66500uq06 and 66642uq07 did not identify any non-conformances or deviations with the likely cause lots.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity c carbon dioxide, lot numbers 66500uq06 and 66642uq07, was identified.
Event or Problem Description
The customer observed falsely decreased alinity c carbon dioxide results for one patient with a history of igg k paraprotein.The following data was provided: sample 1 initial result, on (b)(6) 2025 with serial number (b)(6) and lot number 66642uq07, was 12 mmol/l sample 2 initial result, on (b)(6) 2024 with serial number (b)(6) and lot number 66500uq06, was 12 mmol/l the patient¿s previous results were provided: (b)(6) 2025, at a different site, result was 14, repeat, on a radiometer analyzer, was 28.3 mmol/l; (b)(6) 2024, at a different site, result was 17, repeat result, on a radiometer analyzer, was 25.4 mmol/l; (b)(6) 2010 result with a roche assay was 8, repeat, on the gem, was 27.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: 22322446
• Report Number: 3002809144-2025-00202
• Device Sequence Number: 12992954
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)260131(10)66642UQ07
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

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: 01/31/2026
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2025
• 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 CO2 RGT 3000T, 07P72-20, 66500UQ06; ALNTY C PROCESSING MODU, 03R67-01, AC04773; ALNTY C PROCESSING MODU, 03R67-01, AC04955
• Patient Sex: Unknown