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	04/04/2025
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.
Event or Problem Description
The customer observed falsely depressed alinity c co2 results.The following results were provided (normal co2 range 18-32 mmol/l): instrument sn: (b)(6).Sid (b)(6), (b)(6) 2025, initial result 21 mmol/l, previous result 26 mmol/l, sid (b)(6), (b)(6) 2025, initial result 23 mmol/l, previous result 46 mmol/l (on (b)(6) 2025).Instrument sn: (b)(6).Sid (b)(6), (b)(6) 2025, initial result 20 mmol/l, previous result 26 mmol/l (on (b)(6) 2025), sid (b)(6), (b)(6) 2025, initial result 20 mmol/l, previous result 24 mmol/l (on (b)(6) 2025).No impact to patient management was reported.
Additional Manufacturer Narrative
Corrected data found in section b3 date of event.Data and information provided by the customer were reviewed and support the complaint issue.Return testing was not completed as returns were not available.The customer stated that since they started using a different calibrator lot and replaced the dry tips, they noticed an improvement in co2 results.Review of tracking and trending did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified.Device history review did not identify any non-conformances or deviations with the complaint lot number and complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency was identified.
Event or Problem Description
The customer observed falsely depressed alinity c co2 results.The following results were provided (normal co2 range 18-32 mmol/l): instrument sn: (b)(6).Sid (b)(6), (b)(6) 2025 initial result 21 mmol/l, previous result 26 mmol/l, sid (b)(6), (b)(6) 2025 initial result 23 mmol/l, previous result 46 mmol/l (on (b)(6) 2025).Instrument sn: (b)(6).Sid (b)(6), (b)(6) 2025, initial result 20 mmol/l, previous result 26 mmol/l (on (b)(6) 2025), sid (b)(6), (b)(6) 2025 initial result 20 mmol/l, previous result 24 mmol/l (on (b)(6) 2025).No impact to patient management was 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: 21902078
• Report Number: 3002809144-2025-00141
• Device Sequence Number: 20988432
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)251231(10)67274UQ11
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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: 12/31/2025
• Device Catalogue Number: 07P72-20
• Device Lot Number: 67274UQ11
• 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: 04/04/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/28/2025
• 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: ALINITY C CARBON DIOXID, 08P72-01, 27832FD01; ALNTY C PROCESSING MODU, 03R67-01, (B)(6); ALNTY C PROCESSING MODU, 03R67-01, (B)(6)
• Patient Sex: Unknown