MAUDE Adverse Event Report: Abbott GmbH Alinity c Carbon Dioxide Reagent Kit; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	07P72-20
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported imprecise alinity c carbon dioxide (co2) results generated across multiple alinity c processing modules.The customer stated that the anion gaps were running low.The following data was provided (reference range: 22-29 mmol/l): (b)(6) (b)(6): units: mmol/l sid (b)(6): co2 initial = 30; repeat = 28 sid (b)(6): co2 initial = 30; repeat = 27 sid (b)(6): co2 initial = 30; repeat = 28 sid (b)(6): co2 initial = 31; repeat = 29 sid (b)(6): co2 initial = 22; repeat = 20.Thelma (b)(6): units: mmol/l sid (b)(6): co2 initial = 30; repeat = 28 sid (b)(6): co2 initial = 30; repeat = 28 sid (b)(6): co2 initial = 31; repeat = 28 sid (b)(6): co2 initial = 22; repeat = 21.There was no impact to patient management reported.
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.

• 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 ; +49()6122582960
• MDR Report Key: 50754752
• Report Number: 3002809144-2026-00243
• Device Sequence Number: 15786137
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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 Catalogue Number: 07P72-20
• Device Lot Number: 69848UQ03
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2026
• 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