MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-11
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2025
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.
Event or Problem Description
The customer observed falsely decreased architect total bilirubin generated from architect analyzer and provided the following data: the customer reported that they were getting total bilirubin results < 0.2 mg/dl and upon repeat they were getting actual numbers.The customer communicated that 40 patients' results required correction.The customer confirmed that there was no improper treatment due to the results.Result values not provided, but the following example was provided.On (b)(6) 2025, sample id (b)(6) initial result was < 0.2 mg/dl and repeat result was 0.3 mg/dl.Customer reference range is 0.2-1.3 mg/dl there was no reported impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and replaced the probe wash bellows set, incl rod and fitting (rohs).Additionally, the fsr rebuilt the r2 syringe by replacing the rgt seal tip 1, rgt seal tip 2, and the rgt syr o-rng.Replacement of the parts resolved the issue which was verified with a passing quality control run.No additional discrepant result issues have been reported since the service activity was completed.The instrument service history review for (b)(6) revealed no additional service tickets associated with discrepant/erratic patient results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of tracking did not identify any trends for the parts that were replaced.A review of tracking and trending did not identify any similar issues related to the architect system, likely cause parts, or discrepant results as described in this ticket.A review of manufacturing documentation did not identify any non-conformances related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c8000 processing module, the bellows set, incl rod & fitting (rohs), rgt seal tip 1, rgt seal tip 2, or the rgt syr o-rng was identified.
Event or Problem Description
The customer observed falsely decreased architect total bilirubin generated from architect analyzer and provided the following data: the customer reported that they were getting total bilirubin results < 0.2 mg/dl and upon repeat they were getting actual numbers.The customer communicated that 40 patients' results required correction.The customer confirmed that there was no improper treatment due to the results.Result values not provided, but the following example was provided.On (b)(6) 2025, sample id (b)(6) initial result was < 0.2 mg/dl and repeat result was 0.3 mg/dl.Customer reference range is 0.2-1.3 mg/dl there was no reported impact to patient management.

• Brand Name: ARCHITECT C8000 PROCESSING MODULE
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT LABORATORIES; 1915 hurd drive; irving TX 75038
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23584561
• Report Number: 3016438761-2025-00676
• Device Sequence Number: 9398328
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 12/19/2025

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 Catalogue Number: 01G06-11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2014
• 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: CC TOTAL BILI (3840T), 06L45-42, 67014UQ01; CC TOTAL BILI (3840T), 06L45-42, 67014UQ01
• Patient Sex: Unknown