MAUDE Adverse Event Report: ABBOTT GMBH ALINITY C CARBON DIOXIDE REAGENT KIT; ENZYMATIC, CARBON-DIOXIDE

Catalog Number	07P72-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity c carbon dioxide patient results and quality controls (qc) out of range.The following example data was provided (customer provided reference range: 22 to 31 mmol/l): initial result = 33 mmol/l, repeat after recalibration = 25 mmol/l no impact to patient management was reported.
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 reported falsely elevated alinity c carbon dioxide patient results and quality controls (qc) out of range.The following example data was provided (customer provided reference range: 22 to 31 mmol/l): initial result = 33 mmol/l, repeat after recalibration = 25 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Section g2 - report source: this section was corrected with a removal of foreign.The data and information provided by the customer were reviewed and supported the complaint issue without indication of any additional issues.A search for similar complaints did not identify an increase in complaint activity for lot 68121uq04.A review of tracking and trending for the alinity c carbon dioxide assay did not identify any trends related to the complaint issue.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 68121uq04 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity c carbon dioxide reagent, lot number 68121uq04.

• 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: 23356526
• Report Number: 3002809144-2025-00334
• Device Sequence Number: 15669405
• Product Code: KHS
• UDI-Device Identifier: 00380740121594
• UDI-Public: (01)00380740121594(17)260531(10)68121UQ04
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: 05/31/2026
• Device Catalogue Number: 07P72-20
• Device Lot Number: 68121UQ04
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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)
• Patient Sex: Unknown