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

Catalog Number	04T91-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 observed a falsely elevated creatinine2 on the alinity c processing module for one patient.The following results were provided (reference range <1.2 mg/dl): sid (b)(6), initial creatinine results= 16.42 mg/dl; repeat results using a different method at a different laboratory confirmed the results.The patient was referred to the hospital and the creatinine was repeated and was in normal range using an unknown method (no actual result provided).Additional results were provided: bun= 279.92 mg/dl; potassium= 9.88 mmol/l; cystatin c= 1.25 mg/l there was no impact to patient management reported.
Event or Problem Description
The customer observed a falsely elevated creatinine2 on the alinity c processing module for one patient.The following results were provided (reference range <1.2 mg/dl): sid (b)(6), initial creatinine results= 16.42 mg/dl; repeat results using a different method at a different laboratory confirmed the results.The patient was referred to the hospital and the creatinine was repeated and was in normal range using an unknown method (no actual result provided).Additional results were provided: bun= 279.92 mg/dl; potassium= 9.88 mmol/l; cystatin c= 1.25 mg/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, in house testing and labeling review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the creatinine2 assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 71572ud00.A device history record review did not identify any nonconformances or deviations associated with the complaint issue.In-house testing was completed with a retained kit of the complaint lot number.All validity and acceptance criteria were met and the product is performing as expected.Labeling was reviewed and found to adequately address the issue.Based on the investigation, no systemic issue or deficiency of the creatinine2 assay lot 71572ud00 was identified.

• Brand Name: ALINITY C 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: 22166034
• Report Number: 3005094123-2025-00287
• Device Sequence Number: 9255280
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)260421(10)71572UD00
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/23/2025

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: 04/21/2026
• Device Catalogue Number: 04T91-20
• Device Lot Number: 71572UD00
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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