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	01/15/2026
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 falsely elevated alinity c creatinine results for a 50-year-old female patient.The following data was provided (reference range 0.5 - 1.1 mg/dl): sid (b)(6) initial alinity c creatinine result was 4.52 mg/dl ((b)(6) 2026).This result was questioned by the attending physician.The same sample was measured again on (b)(6) 2026: (b)(6): 0.73 mg/dl, (b)(6): 0.78 mg/dl.No impact to patient management was 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, labeling review, device history record review and in house testing of a retained reagent kit lot 80008ud00.Review of tracking and trending for the alinity c creatinine2 reagent did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 80008ud00.A review in the corrective and preventive actions (capa) system did not identify any nonconformances, potential nonconformance or deviations associated with the complaint assay.In-house specificity testing of a retained kit of lot 80008ud00 was completed.All specifications were met indicating the lot is performing acceptably.Labeling was reviewed and was found to address the customer reported issue.Based on our investigation, no systemic issue or deficiency with the alinity c creatinine2 reagent for lot 80008ud00 was identified.
Event or Problem Description
The customer observed falsely elevated alinity c creatinine results for a 50-year-old female patient.The following data was provided (reference range 0.5 - 1.1 mg/dl): sid (b)(6) initial alinity c creatinine result was 4.52 mg/dl (15jan2026).This result was questioned by the attending physician.The same sample was measured again on 20jan2026: (b)(6): 0.73 mg/dl.(b)(6): 0.78 mg/dl.No impact to patient management was reported.

• 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: 24208301
• Report Number: 3005094123-2026-00045
• Device Sequence Number: 14826461
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)261106(10)80008UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/13/2026

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: 04T91-20
• Device Lot Number: 80008UD00
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• 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 Age: 50 YR
• Patient Sex: Female