MAUDE Adverse Event Report: Abbott Ireland Diagnostics Division ARCHITECT Total Bilirubin2; diazo colorimetry, bilirubin

Catalog Number	04T09-20
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased total bilirubin2 results generated by the architect c4000 processing module for an infant patient.The physician questioned the results associated with sample ids (b)(6).The following data was provided: total bilirubin reference range for infants: 2 to 12 mg/dl (b)(6) 2026 at 10:30 am sid (b)(6) total bilirubin: 11.10 mg/dl.(b)(6) 2026 at 9:53 am sid (b)(6) total bilirubin: 16.6 mg/dl.(b)(6) 2026 at 8:35 pm sid (b)(6) total bilirubin: 17.0 mg/dl.(b)(6) 2026 at 10:22 am sid (b)(6) total bilirubin: 8.2 mg/dl.(b)(6) 2026 at 12:11 pm sid (b)(6) total bilirubin: 7.30 mg/dl.(b)(6) 2026 at 3:22 pm sid (b)(6) total bilirubin: 18.4 mg/dl this sample was analyzed at another facility using the alinity platform.(b)(6) 2026 at 11:22 am sid (b)(6) total bilirubin: 19.10 mg/dl (b)(6) 2026 at 11:05 am sid (b)(6) total bilirubin: 17.90 mg/dl results marked with an asterisk (*) were questioned by the physician.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

• 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 ; +49()6122582960
• MDR Report Key: 50801169
• Report Number: 3005094123-2026-00469
• Device Sequence Number: 13397852
• Product Code: CIG
• UDI-Device Identifier: 00380740167561
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K223324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 10/01/2026
• Device Catalogue Number: 04T09-20
• Device Lot Number: 77234UD00
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2025
• 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 C4000 INTGR, 02P24-40, C403369
• Patient Sex: Unknown