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

Catalog Number	04T91-20
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
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.Section a patient information: refer to section b5 for complete patient information continued information in section e1 phone number: (b)(6).
Event or Problem Description
The customer observed imprecise alinity c creatinine2 results generated on an alinity c processing module for multiple patients.The following data was provided (reference ranges: male 0.60 to 1.30 mg/dl): sid (b)(6) (74 year old male) initial result on (b)(6) = 2.37 mg/dl, repeat result on (b)(6) = 1.36 mg/dl sid (b)(6) (80-year-old female) initial result on (b)(6) = 0.19 mg/dl, repeat result on (b)(6) = 3.39 mg/dl.There was no impact to patient management.
Event or Problem Description
The customer observed imprecise alinity c creatinine2 results generated on an alinity c processing module for multiple patients.The following data was provided (reference ranges: male 0.60 to 1.30 mg/dl): sid (b)(6) (74 year old male) initial result on (b)(6) = 2.37 mg/dl, repeat result on (b)(6) = 1.36 mg/dl sid (b)(6) (80-year-old female) initial result on (b)(6) = 0.19 mg/dl, repeat result on (b)(6) = 3.39 mg/dl.There was no impact to patient management.
Additional Manufacturer Narrative
A complaint investigation was conducted for the alinity c creatinine2 reagent lot 79494ud00 to address the customer¿s observation of imprecise results.Review of tracking and trending by list number and by complaint lot did not identify any trends.Device history review did not identify issues associated with the customer¿s observation.Retain testing of reagent lot 79494ud00 met all acceptance criteria and the product is performing as expected.From the review performed it has been determined that there is sufficient labelling to aid the customer in troubleshooting this issue.Based on our investigation, no systemic issue or deficiency was identified with the alinity c creatinine2 reagent lot 79494ud00.

• 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: 25010190
• Report Number: 3005094123-2026-00195
• Device Sequence Number: 10462743
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)261106(10)79494UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 05/05/2026

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: 04T91-20
• Device Lot Number: 79494UD00
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/05/2026
• 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, N/S (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, N/S (B)(6).
• Patient Sex: Unknown