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

Catalog Number	04U05-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier, a2 - age at time of event, a2 - age units (patient), a3a - sex: patient 1 (72-year-old female), patient 2 (46-year-old female), patient 3 (44-year-old female).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated total bilirubin2 results generated by the alinity c processing module for multiple patients.Physicians questioned these results as they were inconsistent with prior patient results.The following data were provided: customer¿s reference range (adults): 0.3 ¿ 1.2 mg/dl patient 1 (72-year-old female): (b)(6) 2025: 1.5 mg/dl.Previous ((b)(6) 2025): 0.5 mg/dl.Patient 2 (46-year-old female): (b)(6) 2025: 2.1 mg/dl.Previous (b)(6) 2025): 0.3 mg/dl.Patient 3 (44-year-old female): (b)(6) 2025: 2.6 mg/dl.Previous ((b)(6) 2025): 0.5 mg/dl.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated total bilirubin2 results generated by the alinity c processing module for multiple patients.Physicians questioned these results as they were inconsistent with prior patient results.The following data were provided: customer¿s reference range (adults): 0.3 ¿ 1.2 mg/dl.Patient 1 (72-year-old female): (b)(6) 2025: 1.5 mg/dl.Previous ((b)(6) 2025): 0.5 mg/dl.Patient 2 (46-year-old female): (b)(6) 2025: 2.1 mg/dl.Previous ((b)(6) 2025): 0.3 mg/dl.Patient 3 (44-year-old female): (b)(6) 2025: 2.6 mg/dl.Previous ((b)(6) 2025): 0.5 mg/dl, no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated total bilirubin2 using the alinity c consolidated chemistry calibrator (concc) lot 0001427ue included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.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 concc did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 0001427ue.A device history record review for the lot number did not identify any non-conformances, potential non-conformances, or deviations associated with the complaint lot and complaint issue.A review of the labeling addresses the customer¿s issue.The alinity c concc package insert storage section identifies the special storage conditions for the total bilirubin2 assay.In this case, the customer performed calibrations using the alinity c concc past the open expiry of 24 hours for the total bilirubin2 assay.Based on the investigation the alinity c concc lot 0001427ue using reagent lot 79220ud00 is performing as intended, no systemic issue or deficiency of the total bilirubin2 reagent was identified.

• 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: 24038890
• Report Number: 3005094123-2026-00014
• Device Sequence Number: 21147407
• Product Code: CIG
• UDI-Device Identifier: 00380740167585
• UDI-Public: (01)00380740167585(17)261118(10)79220UD00
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 04U05-20
• Device Lot Number: 79220UD00
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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: ALINITY CONCC, 04V62-01, 0001427UE.; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).; ALNTY C PROCESSING MODU, 03R67-01, (B)(6).
• Patient Sex: Unknown