MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-01
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: patient 1 (sid (b)(6), patient 2 (sid (b)(6), patient 3 (sid not provided).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 total bilirubin results generated by the architect c4000 processing module for multiple patients.The samples were repeated, and normal results were obtained.The following data was provided: customer¿s normal reference range: 0.2 to 1.3 mg/dl.Patient 1: on (b)(6) 2025, sid (b)(6), initial result = <0.1 mg/dl; repeat result = 0.408 mg/dl.Patient 2: on (b)(6) 2025, sid (b)(6), initial result = <0.1 mg/dl; repeat result = 0.367 mg/dl.Patient 3: on (b)(6) 2025, sid (not provided), initial result = 0.1 mg/dl: repeat result = 0.2 mg/dl.There was no impact to patient management reported.
Event or Problem Description
The customer observed falsely decreased total bilirubin results generated by the architect c4000 processing module for multiple patients.The samples were repeated, and normal results were obtained.The following data was provided: customer¿s normal reference range: 0.2 to 1.3 mg/dl patient 1: on (b)(6) 2025, sid (b)(6), initial result = <0.1 mg/dl; repeat result = 0.408 mg/dl.Patient 2: on (b)(6) 2025, sid (b)(6), initial result = <0.1 mg/dl; repeat result = 0.367 mg/dl.Patient 3: on (b)(6) 2025, sid (not provided) initial result = 0.1 mg/dl: repeat result = 0.2 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
The customer inspected the instrument, performed quarterly maintenance, replaced and calibrated the sample probe, but was unable to identify a single part as the likely cause of the issue.The architect c4000, serial number (b)(6), was considered the likely cause of the result issue.A review of instrument service history for (b)(6) revealed no additional tickets associated with discrepant or 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 complaint and trending data for the architect c4000 processing module did not identify an increase in complaint activity.The device history record was reviewed, and no non-conformances or deviations were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect c4000 processing module, serial number (b)(6), was identified.

• Brand Name: ARCHITECT C4000 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: 22059171
• Report Number: 3016438761-2025-00297
• Device Sequence Number: 7634777
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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 Catalogue Number: 02P24-01
• 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: 05/01/2025
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• 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 (2750T), 06L45-22, 66260UQ05; CC TOTAL BILI (2750T), 06L45-22, 66260UQ05
• Patient Sex: Unknown