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

Catalog Number	04T09-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect total bilirubin2 results for a 48-hour old newborn patient.Results were reported to medical provider.The following data provided.Initial result =18.6 mg/dl, repeat results from roche (sevgi hospital) =14.6 mg/dl, roche (training and research hospital) =15.7mg/dl.Reference range: abbott; 0¿8mg/dl (24 hrs.), 0¿12mg/dl (48 hrs.).Reference range; roche; 0¿8 mg/dl (24 hrs.), 0¿13 mg/dl (48 hrs.).Physician only question results for total bilirubin.Additional direct bilirubin results provided.Initial result 0.68, repeat result (roche) 1.32.Reference range: 0¿0.5 abbott and 0¿0.58 from roche.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included, no additional patient information was available.
Additional Manufacturer Narrative
Review of tracking and trending data by list number and by complaint lot did not identify any trends.Review of the corrective and preventive actions system did not identify any issues associated with the customer¿s observation.In house accuracy testing was performed to evaluate assay performance using retained samples of architect total bilirubin2 reagent lot 75229ud00.All validity and acceptance criteria were met indicating that 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 architect total bilirubin2 reagent lot 75229ud00 was identified.
Event or Problem Description
The customer reported falsely elevated architect total bilirubin2 results for a 48-hour old newborn patient.Results were reported to medical provider.The following data provided.Initial result =18.6 mg/dl, repeat results from roche (b)(6) =14.6 mg/dl, (b)(6) =15.7mg/dl.Reference range: abbott; 0¿8mg/dl(24 hrs.), 0¿12mg/dl(48 hrs.) reference range; roche; 0¿8 mg/dl (24 hrs.), 0¿13 mg/dl (48 hrs.) physician only question results for total bilirubin.Additional direct bilirubin results provided.Initial result 0.68, repeat result (roche) 1.32.Reference range: 0¿0.5 abbott and 0¿0.58 from roche no impact to patient management was reported.

• Brand Name: ARCHITECT 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: 24208456
• Report Number: 3005094123-2026-00043
• Device Sequence Number: 12120357
• Product Code: CIG
• UDI-Device Identifier: 00380740167578
• UDI-Public: (01)00380740167578(17)260729(10)75229UD00
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K223324
• 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): 04/14/2026

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: 07/29/2026
• Device Catalogue Number: 04T09-30
• Device Lot Number: 75229UD00
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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: ARC C8 PROC MOD, 01G06-11, C804185; ARC C8 PROC MOD, 01G06-11, C804185
• Patient Age: 2 DA
• Patient Sex: Unknown