MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY C TOTAL BILIRUBIN2; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	04U05-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2025
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.A1 - patient identifier: (b)(6) (complete patient identifier).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely depressed alinity i total bilirubin results for one 83-year-old female patient.The following data was provided: sid (b)(6), ac07510, 15nov2025, bili t 0.38; repeated bili t 0.45; ac07511, 15nov2025, bili t 0.40.The sample was sent to another cac laboratory: bili t 0.50 (colorimetric method).No impact to patient management was reported.
Additional Manufacturer Narrative
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 alinity c total bilirubin2 assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 74016ud00.Device history record review did not identify any nonconformances, potential nonconformances, or deviations associated with the complaint lot and complaint issue.In house accuracy testing was performed using retained samples of alinity c total bilirubin2 reagent lot 74016ud00.All validity and acceptance criteria have been met.The product is performing as expected.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity c total bilirubin2 reagent lot 74016ud00 was identified.
Event or Problem Description
The customer observed falsely depressed alinity c total bilirubin results for one 83-year-old female patient.The following data was provided: sid (b)(6), (b)(6) 2025 bili t 0.38; repeated bili t 0.45, (b)(6) 2025 bili t 0.40.The sample was sent to another cac laboratory: bili t 0.50 (colorimetric method).No impact to patient management was reported.

• Brand Name: ALINITY C TOTAL BILIRUBIN2
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: 23715758
• Report Number: 3005094123-2025-00611
• Device Sequence Number: 12973111
• Product Code: CIG
• UDI-Device Identifier: 00380740167585
• UDI-Public: (01)00380740167585(17)260505(10)74016UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121985
• 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): 02/16/2026

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: 05/05/2026
• Device Catalogue Number: 04U05-20
• Device Lot Number: 74016UD00
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2025
• 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: 83 YR
• Patient Sex: Female