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	06/26/2025
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.All available patient information was included.Additional patient details are not available.Section a1 patient identifier sids: (b)(6).
Event or Problem Description
The customer reported falsely decreased total bilirubin results on multiple patients.Results provided: all initial results were <0.10 mg/dl.Sid repeat result (b)(6), 5.10, (b)(6), 2.84, (b)(6), 0.43, (b)(6), 0.21, (b)(6), 0.15, (b)(6), 0.25, (b)(6), 4.45, (b)(6), 0.34, (b)(6), 0.26, (b)(6), 0.38, (b)(6), 0.48, (b)(6), 0.27.No impact to patient management was reported.
Additional Manufacturer Narrative
Abbott field service (fs) investigated the issue on site.The analyzer was inspected, and various diagnostic checks of the system, cleaning, and parts adjustment were performed.There have been no further issues results since the fse was on-site.A review of the architect sn# (b)(4) service history was not able to identify or confirm any additional likely causes.A review of historical data revealed no trends, systemic issues, or related nonconformances.A review of the clinical chemistry systems revealed found no systemic issues or trends for the issue associated with this ticket.Manufacturing documentation for the likely cause did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the architect c8000 analyzer.
Event or Problem Description
The customer reported falsely decreased total bilirubin results generated on the architect c8000 processing module on multiple patients.Results provided: all initial results were <0.10 mg/dl.Sid repeat result 3002539034 5.10 3002539004 2.84 3002538927 0.43 3002538905 0.21 3002538890 0.15 3002538790 0.25 3002538776 4.45 3002538738 0.34 3002538717 0.26 3002538715 0.38 3002538443 0.48 3002537992 0.27 no impact to patient management was reported.

• 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: 22505373
• Report Number: 3016438761-2025-00402
• Device Sequence Number: 15637413
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 08/20/2025

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: 06/28/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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, 66655UQ06; CC TOTAL BILI (3840T), 06L45-42, 66655UQ06
• Patient Sex: Unknown