MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CREATININE; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number	03L81-33
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
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 was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated creatinine result generated on the architect c16000 processing module on a patient.Results provided: sid (b)(6) = 689 / 62.3 umol/l (reference range: 57-111 umol/l) no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect creatinine results 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.A review of tracking and trending for the product and the reagent lot did not identify an increase in complaint activity.As part of troubleshooting, the sample was retested and gave a lower result.The sample was retested using the same lot of reagent.Quality control (qc) results were reported to be within expected ranges.Device history record review did not identify any non-conformances or deviations with the lot and complaint issue.Manufacturing documentation for the lot was reviewed and did not identify any issues.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 architect creatinine, lot number 14446un25, was identified.
Event or Problem Description
The customer reported a falsely elevated creatinine result generated on the architect c16000 processing module on a patient.Results provided: sid (b)(6) = 689 / 62.3 umol/l (reference range: 57-111 umol/l) no impact to patient management was reported.

• Brand Name: ARCHITECT CREATININE
• Common Device Name: ALKALINE PICRATE, COLORIMETRY, CREATININE
• 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: 23879374
• Report Number: 3002809144-2025-00407
• Device Sequence Number: 15818770
• Product Code: CGX
• UDI-Device Identifier: 00380740161569
• UDI-Public: (01)00380740161569(17)261023(10)14446UN25
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083809
• 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): 03/05/2026

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: 03L81-33
• Device Lot Number: 14446UN25
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2025
• 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 C16K PRC MOD, 03L77-01, (B)(6); ARC C16K PRC MOD, 03L77-01, (B)(6)
• Patient Sex: Unknown