MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT TOTAL BILIRUBIN; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	06L45-22
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2025
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: complete list of sample id's are (b)(6).
Event or Problem Description
The customer reported falsely decreased bilirubin generated from architect analyzer.After recalibration, retesting generated normal results.The customer provided the following data: customer normal range: 3.4-20.5 mol/l.Sample id (b)(6) initial result was 2.7 and repeat result was 4.1.Sample id (b)(6) initial result was 2.4 and repeat result was 3.8.Sample id (b)(6) initial result was 2.4 and repeat result was 3.7.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.
Additional Manufacturer Narrative
The customer observed falsely depressed total bilirubin results for multiple patient samples while using the architect total bilirubin, lot number 67337uq11.As part of troubleshooting the blank calibration was checked which displayed a slightly elevated calibration curve.Recalibration was performed and the questioned patient samples were retested using the same lot of reagent, generating within range results.The quality control (qc) results were within range at the time of testing.The ticket search by lot did not identify an increase in complaint activity for the complaint issue.Tracking and trending for the architect total bilirubin assay did not identify any related trends.Device history review did not identify any nonconformances or deviations associated with the complaint lot number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of the architect total bilirubin, lot 67337uq11 was identified.
Event or Problem Description
The customer reported falsely decreased bilirubin generated from architect analyzer.After recalibration, retesting generated normal results.The customer provided the following data: customer normal range: 3.4-20.5 mol/l, sample id (b)(6), initial result was 2.7 and repeat result was 4.1, sample id (b)(6), initial result was 2.4 and repeat result was 3.8 , sample id (b)(6), initial result was 2.4 and repeat result was 3.7.Per the customer the discrepant results were not reported out to the patient¿s medical provider.There was no reported impact to patient management.

• Brand Name: ARCHITECT TOTAL BILIRUBIN
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23866607
• Report Number: 3002809144-2025-00405
• Device Sequence Number: 14788289
• Product Code: CIG
• UDI-Device Identifier: 00380740174965
• UDI-Public: (01)00380740174965(17)260430(10)67337UQ11
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/09/2026

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: 04/30/2026
• Device Catalogue Number: 06L45-22
• Device Lot Number: 67337UQ11
• 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: 12/14/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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 C16K PRC MOD, 03L77-01, C1602093; ARC C16K PRC MOD, 03L77-01, C1602093
• Patient Sex: Unknown