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	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1: patient identifier: complete sample id is (b)(6).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 elevated creatinine2 results generated by the alinity c processing module for a patient, which were inconsistent with the patient¿s clinical picture and the enzymatic creatinine result.The following data was provided: on (b)(6) 2025 creatinine2 results = 3.36, 3.43, and 3.44 mg/dl.On (b)(6) 2025 sid: (b)(6): creatinine2 result = 3.75 mg/dl.Enzymatic creatinine result = <0.10 mg/dl (reference range is 0.72 to 1.3 mg/dl).Other results provided: cystatic c result = normal.Urea result = normal.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated creatinine2 results generated by the alinity c processing module for a patient, which were inconsistent with the patient¿s clinical picture and the enzymatic creatinine result.The following data was provided: (b)(6) 2025 creatinine2 results = 3.36, 3.43, and 3.44 mg/dl.(b)(6) 2025 sid (b)(6): creatinine2 result = 3.75 mg/dl.Enzymatic creatinine result = <0.10 mg/dl (reference range is 0.72 to 1.3 mg/dl).Other results provided: cystatic c result = normal.Urea result = normal.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated creatinine2 results included a review of data and information provided by the customer, a search for similar complaints, a ticket trending review, a device history record review, and a labeling review.In-house testing of retained reagent kit was also completed.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did not identify an increase in complaint activity for lot 70002ud00.A review of tracking and trending for the creatinine2 assay (list number 04t91) did not identify an increase in complaint activity related to the complaint issue.A review of the device history record did not identify any non-conformances or deviations with lot number 70002ud00 and the complaint issue.A review of labeling was performed and found to sufficiently address the customer¿s issue.In-house accuracy testing was performed using retained reagent kit of the complaint lot, and all specifications were met, indicating that the lot is performing as expected.Based on this investigation, no systemic issue or deficiency with the creatinine2 reagent, lot number 70002ud00, 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: 22017961
• Report Number: 3005094123-2025-00237
• Device Sequence Number: 8641767
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)260201(10)70002UD00
• 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): 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): 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: 02/01/2026
• Device Catalogue Number: 04T91-20
• Device Lot Number: 70002UD00
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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