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	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on feb 16 in the morning an alinity c creatinine2 reagent kit sn (b)(6) was loaded onto the alinity c processing module, lot 65446ud00, which generated several instrument errors of "1039 unable to calculate the result.Absorbance exceeded the optical limit" prior to generating the falsely depressed alinity c creatinine2 results that were not released.The customer processed internal quality control which also generated low results.The customer changed the reagent kit to sn 06319 and repeat testing was done on feb 17, and it was confirmed that the results returned to perform as expected.The following data was provided: sid (b)(6): initial crea2 result = < 0.10 mg/dl; repeat result = 8.95 mg/dl.Sid (b)(6): initial crea2 result = < 0.10 mg/dl; repeat result = 4.68 mg/dl.Sid (b)(6): initial crea2 result = < 0.10 mg/dl; repeat result = 2.71 mg/dl.The customer¿s reference range for creatinine: male: 0.80 to 1.28 mg/dl / female: 0.55 to 1.02 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1 - patient identifier: (b)(6) (total of 3 patients).All available patient information was included.Additional patient details are not available.
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 kit of the complaint lot.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.A review of tracking and trending for the alinity c 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 65446ud00.A review of the device history record did not identify any nonconformance or deviation associated for lot 65446ud00 related to the complaint issue.Retain testing using reagent lot 65446ud00 met all acceptance criteria and the product is performing as expected.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency of the alinity c creatinine2 reagent lot 65446ud00 was identified.
Event or Problem Description
The customer reported on feb 16 in the morning an alinity c creatinine2 reagent kit sn (b)(6) was loaded onto the alinity c processing module, lot 65446ud00, which generated several instrument errors of "1039 unable to calculate the result.Absorbance exceeded the optical limit" prior to generating the falsely depressed alinity c creatinine2 results that were not released.The customer processed internal quality control which also generated low results.The customer changed the reagent kit to sn 06319 and repeat testing was done on feb 17, and it was confirmed that the results returned to perform as expected.The following data was provided: sid (b)(6): initial crea2 result = < 0.10 mg/dl; repeat result = 8.95 mg/dl; sid (b)(6): initial crea2 result = < 0.10 mg/dl; repeat result = 4.68 mg/dl; sid (b)(6): initial crea2 result = < 0.10 mg/dl; repeat result = 2.71 mg/dl.The customer¿s reference range for creatinine: male: 0.80 to 1.28 mg/dl / female: 0.55 to 1.02 mg/dl there was no impact to patient management 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: 21590253
• Report Number: 3005094123-2025-00108
• Device Sequence Number: 8219998
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)250926(10)65446UD00
• 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): 04/02/2025

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: 09/26/2025
• Device Catalogue Number: 04T91-20
• Device Lot Number: 65446UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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, AC07040; ALNTY C PROCESSING MODU, 03R67-01, AC07040
• Patient Sex: Unknown