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	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During the site visit, the abbott field service (fsr) inspected the module and the tbg, r2drain, sealed tank-valve (rohs) the likely cause, due to the r1 and r2 wash cup tubing being clogged.The tbg, r2drain, sealed tank-valve (rohs) was cleaned and considered the issue resolution.The instrument service history for the architect c8000, serial number (b)(6) verifies no subsequent issues have been reported related to false decreased patient results after service intervention.The architect system operations manual provides adequate labeling with regards to maintenance and troubleshooting the customer¿s issue involving the erratic results.The c8000 service and support manual contained adequate information for troubleshooting, removing and installing parts.A review of the architect c8000 processing module tracking, and trending data revealed no systemic issues or trends associated with the discrepant result described in this complaint.A review of historical data for the tbg, r2drain, sealed tank-valve associated with this complaint, revealed no trends, systemic issues, or nonconformances.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation, no product deficiency was identified for either the architect c8000 processing module, serial number c804394, or the tbg, r2drain, sealed tank-valve.
Event or Problem Description
The customer observed falsely decreased total bilirubin assay results generated from architect c8000 processing module for a 58yrs old male patient.The results provided were: on (b)(6) 2026 sid (b)(6) initial=0.16 mg/dl /repeated=2.03 and 2.05 mg/dl.Laboratory reference range for total bilirubin=0.30 to 1.20 mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely decreased total bilirubin assay results generated from architect c8000 processing module for a 58yrs old male patient.The results provided were: on (b)(6) 2026, sid (b)(6), initial=0.16 mg/dl /repeated=2.03 and 2.05 mg/dl laboratory reference range for total bilirubin=0.30 to 1.20 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: 25191218
• Report Number: 3016438761-2026-00273
• Device Sequence Number: 10427845
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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,Followup
• Report Date (Section B): 05/22/2026

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 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: 05/04/2026
• Supplement Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2017
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC TBILI2 KIT 900T, 04T09-20, 77234UD00; ARC TBILI2 KIT 900T, 04T09-20, 77234UD00
• Patient Age: 58 YR
• Patient Sex: Male