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	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect total bilirubin2 results for multiple patient samples.The following data was provided (units of measure are umol/l): specid (b)(6): original result reported out = 161, current calibrator result = 98.55, new calibrator result = 99.68, new calibrator (recalibration result) = 99.16 specid (b)(6): original result reported out = 96, current calibrator result = 67.44, new calibrator result = 68.31, new calibrator (recalibration result) = 67.15 specid (b)(6): original result reported out = 150, current calibrator result = 122.27, new calibrator result = 122.89, new calibrator (recalibration result) = 122.68 specid (b)(6): original result reported out = 197, current calibrator result = 139.45, new calibrator result = 139.89, new calibrator (recalibration result) = 141.32 specid (b)(6): original result reported out = 195, current calibrator result = 156.39, new calibrator result = 155.97, new calibrator (recalibration result) = 156.68 specid (b)(6): original result reported out = 39, current calibrator result = 9.12, new calibrator result = 8.64, new calibrator (recalibration result) = 8.58 specid (b)(6): original result reported out = 138, current calibrator result = 106.36, new calibrator result = 108.33, new calibrator (recalibration result) = 107.97 specid (b)(6): original result reported out = 49, current calibrator result = 130.98, new calibrator result = 113.53, new calibrator (recalibration result) = 116.82 specid (b)(6): original result reported out = 69, current calibrator result = 53.46, new calibrator result = 53.19, new calibrator (recalibration result) = 51.74 specid (b)(6): original result reported out = 217, current calibrator result = 151.96, new calibrator result = 152.31, new calibrator (recalibration result) = 151.91 specid (b)(6): original result reported out = 244, current calibrator result = 169.46, new calibrator result = 170.87, new calibrator (recalibration result) = 172.41 no impact to patient management was reported.
Additional Manufacturer Narrative
Section a1 patient identifier: (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The customer observed a positive bias for neonatal patient samples at higher concentrations when compared to the legacy total bilirubin assay, while using architect total bilirubin2 reagent lot 71289ud00.It was noted that multiple consolidated chemistry calibrator (concc) lots were tested to compare the patient results, and no significant difference was observed.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending for the architect total bilirubin2 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 71289ud00.Device history review did not identify any potential non-conformances, non-conformances and deviations associated with the lot number 71289ud00 and complaint issue.The total bilirubin2 assay is a newly reformulated assay which is traceable to the doumas reference method, whereas total bilirubin assay is traceable to srm 916b, which can result in shifted values.The assay is designed to meet a difference of =10% for values =2.0 mg/dl or ±0.2 mg/dl for values <2.0 mg/dl relative to recognized method or standard within the medical decision range.Accuracy studies were conducted using serum samples standardized to the doumas total bilirubin reference method.For the architect total bilirubin2 assay, the observed bias ranged from -0.1% to 3.7%.For the original architect total bilirubin assay, the bias ranged from -4% to -1%.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect total bilirubin2 reagent lot 71289ud00 was identified.
Event or Problem Description
The customer reported falsely elevated architect total bilirubin2 results for multiple patient samples.The following data was provided (units of measure are umol/l): specid (b)(6): original result reported out = 161, current calibrator result = 98.55, new calibrator result = 99.68, new calibrator (recalibration result) = 99.16 , specid (b)(6): original result reported out = 96, current calibrator result = 67.44, new calibrator result = 68.31, new calibrator (recalibration result) = 67.15, specid (b)(6): original result reported out = 150, current calibrator result = 122.27, new calibrator result = 122.89, new calibrator (recalibration result) = 122.68, specid (b)(6): original result reported out = 197, current calibrator result = 139.45, new calibrator result = 139.89, new calibrator (recalibration result) = 141.32, specid (b)(6): original result reported out = 195, current calibrator result = 156.39, new calibrator result = 155.97, new calibrator (recalibration result) = 156.68, specid (b)(6): original result reported out = 39, current calibrator result = 9.12, new calibrator result = 8.64, new calibrator (recalibration result) = 8.58, specid (b)(6): original result reported out = 138, current calibrator result = 106.36, new calibrator result = 108.33, new calibrator (recalibration result) = 107.97, specid (b)(6): original result reported out = 49, current calibrator result = 130.98, new calibrator result = 113.53, new calibrator (recalibration result) = 116.82, specid (b)(6): original result reported out = 69, current calibrator result = 53.46, new calibrator result = 53.19, new calibrator (recalibration result) = 51.74, specid (b)(6): original result reported out = 217, current calibrator result = 151.96, new calibrator result = 152.31, new calibrator (recalibration result) = 151.91, specid (b)(6): original result reported out = 244, current calibrator result = 169.46, new calibrator result = 170.87, new calibrator (recalibration result) = 172.41.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: 23221192
• Report Number: 3005094123-2025-00502
• Device Sequence Number: 9403841
• Product Code: CIG
• UDI-Device Identifier: 00380740167578
• UDI-Public: (01)00380740167578(17)260304(10)71289UD00
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/16/2025

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: 03/04/2026
• Device Catalogue Number: 04T09-30
• Device Lot Number: 71289UD00
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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, C803731; ARC C8 PROC MOD, 01G06-11, C803731
• Patient Sex: Unknown