MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT CREATININE2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	04S95-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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.All available patient information has been included.No additional patient details are available.
Event or Problem Description
The customer reported falsely elevated creatinine2 results generated by the architect c8000 processing module for a patient.A new blood sample was drawn and yield a normal result.The following data was provided: normal reference ranges: creatinine2: 0.60 to 1.30 mg/dl.Sid (b)(6): (b)(6) 2025 creatinine2 initial result = 7.84 mg/dl, repeat results ((b)(6) 2025) = 2.67 and 2.69 mg/dl.Sid (b)(6) (new blood draw for the same patient): (b)(6) 2025 creatinine2 result = 0.68 mg/dl.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated creatinine2 results generated by the architect c8000 processing module for a patient.A new blood sample was drawn and yield a normal result.The following data was provided: normal reference ranges: creatinine2: 0.60 to 1.30 mg/dl.Sid (b)(6): 29dec2025 creatinine2 initial result = 7.84 mg/dl, repeat results ((b)(6) 2025) = 2.67 and 2.69 mg/dl.Sid (b)(6) (new blood draw for the same patient): (b)(6) 2025 creatinine2 result = 0.68 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
Tracking and trending data review found no trends for the architect creatinine2 reagent and lot 71560ud00 related to this issue.A review of the device history record did not identify any nonconformances or deviations with the complaint lot related to this issue.Testing of a retained kit of architect creatinine2 reagent lot 71560ud00 met all acceptance criteria indicating the product is performing as expected.A review of the product labeling concluded that the issue is sufficiently addressed.Sample integrity could not be ruled as a contributing factor.The architect creatinine2 package inserts outline reagent and specimen handling procedures and the architect system operations manual provides instructions and troubleshooting information for the customer when they obtain elevated concentrations.Based on the investigation no systemic issue or product deficiency was identified.

• Brand Name: ARCHITECT CREATININE2
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 24019256
• Report Number: 3005094123-2026-00010
• Device Sequence Number: 10590926
• Product Code: CGX
• UDI-Device Identifier: 00380740159535
• UDI-Public: (01)00380740159535(17)260311(10)71560UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K210452
• 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): 03/27/2026

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: 03/11/2026
• Device Catalogue Number: 04S95-20
• Device Lot Number: 71560UD00
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• 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: ARC C8 PROC MOD, 01G06-11, (B)(6).; ARC C8 PROC MOD, 01G06-11, (B)(6).
• Patient Sex: Unknown