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	05/05/2025
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 creatinine 2 results generated on the alinity c processing module for one sample.The following results were provided: sid (b)(6); initial result = 3.78 mg/dl, repeat result on siemens exl = 0.86 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated creatinine2 results 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.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.Review of tracking and trending for the 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 68108ud00.The device history record review did not identify any non-conformances and deviations related to the likely cause lot number and complaint issue.Accuracy testing was performed to evaluate the performance of the reagent lot 68108ud00.All validity and acceptance criteria as per the protocol were met and the product is performing as expected.Labeling was reviewed and sufficiently addresses the customer's issue.A sample integrity issue was acknowledged by the customer as the sample contained particulate matter and gel clots.For accurate results, serum and plasma specimens should be free of fibrin, red blood cells, and other particulate matter.To ensure consistency in results, specimens should be recentrifuged prior to testing if they contain fibrin, red blood cells, or other particulate matter.If fibrin, red blood cells, or other particulate matter are observed, samples should be mixed by low-speed vortex or by inverting 10 times prior to recentrifugation.Based on the information within the complaint record, the device met performance specifications and performed as intended at the customer site, therefore there is no systemic issue or deficiency with the creatinine2 reagent kit for lot number 68108ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated creatinine2 results generated on the alinity c processing module for one sample.The following results were provided: sid (b)(6), initial result = 3.78 mg/dl, repeat result on siemens exl = 0.86 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: 22070088
• Report Number: 3005094123-2025-00249
• Device Sequence Number: 9500788
• Product Code: CGX
• UDI-Device Identifier: 00380740159528
• UDI-Public: (01)00380740159528(17)251130(10)68108UD00
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 06/24/2025

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: 11/30/2025
• Device Catalogue Number: 04T91-20
• Device Lot Number: 68108UD00
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2024
• 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