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	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely decreased results for multiple assays generated on architect c8000 processing module for multiple patients.The one result example provided were: initial sodium=103 mmol/l /repeated on another analyzer=140 mmol/l, laboratory reference range for sodium=136 to 145 mmol/l, there was no reported impact to patient management.
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
During the requested site visit, the field service representative (fsr) inspected and performed multiple troubleshooting procedures including part replacement the tbg, ict valve nc-ict module (rohs) (7-93269-01) and cup, ict-ref with probes, rohs (7-93508-02) which resolved the issue.A review of the architect c8000 processing module, serial number (b)(6).Service history found no contributing factors on or around the date of the complaint.A review of complaint and trending data for the architect c8000 processing module did not identify any similar issues as described in this complaint.Additionally review of complaint and trending data associated with the tbg, ict valve nc-ict module (rohs) and cup, ict-ref with probes, rohs did not identify an increase in complaint activity.Device history record review did not identify any non-conformances or deviations with the likely cause lot(s) and complaint issue.The architect system operations manual provides adequate information regarding the troubleshooting of erratic/discrepant results.The architect c8000 system service and support manual provides instruction for the removal, replacement, and verification of the tbg, ict valve nc-ict module (rohs) and cup, ict-ref with probes, rohs.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 the architect c8000, serial number (b)(6), or tbg, ict valve nc-ict module (rohs) and cup, ict-ref with probes, rohs.
Event or Problem Description
The customer observed falsely decreased results for multiple assays generated on architect c8000 processing module for multiple patients.The one result example provided were: initial sodium=103 mmol/l /repeated on another analyzer=140 mmol/l.Laboratory reference range for sodium=136 to 145 mmol/l 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: 22884457
• Report Number: 3016438761-2025-00495
• Device Sequence Number: 9604939
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/04/2025

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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• 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
• Patient Sex: Unknown