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

Catalog Number	04T91-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Completed information for section a patient information: sid (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A final report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely depressed alinity c creatinine results for on a patient.Result was not reported to medical provider.The following data was provided: on (b)(6) 2026, sid (b)(6); initial result 1.10 mg/dl.Sample was repeated on another processing modules and results are listed as below for same sid.(b)(6) ,(b)(6), 12:46): 2.21 mg/dl, (b)(6), (b)(6), 13:50): 2.34 mg/dl, (b)(6), (b)(6), 14:31): 2.26 mg/dl, (b)(6), (b)(6), 14:32): 2.23 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot 75242ud00 performs as expected for this product.A review of tracking and trending for the creatinine2 assay did not identify any related trends.A review of the device history record did not identify any non-conformances, potential non-conformance or deviations with the complaint lot and complaint issue.In-house testing of a retained reagent kit of the complaint lot was performed.All specifications were met, indicating that the lot performs as expected.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the creatinine2 reagent, lot number 75242ud00.
Event or Problem Description
The customer reported falsely depressed alinity c creatinine results for on a patient.Result was not reported to medical provider.The following data was provided: (b)(6) 2026, sid (b)(6); initial result 1.10 mg/dl.Sample was repeated on another processing modules and results are listed as below for same sid.(b)(6), (b)(6), 12:46): 2.21 mg/dl, (b)(6), (b)(6), 13:50): 2.34 mg/dl, (b)(6), (b)(6), 14:31): 2.26 mg/dl, (b)(6), (b)(6), 14:32): 2.23 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: 24262127
• Report Number: 3005094123-2026-00055
• Device Sequence Number: 9550072
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)260718(10)75242UD00
• 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): 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): 02/16/2026

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 Expiration Date: 07/18/2026
• Device Catalogue Number: 04T91-20
• Device Lot Number: 75242UD00
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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