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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed discrepant results generated from architect c8000 processing module for several patients.The one result example provided were: sid (b)(6) creatinine initial=1.65 mg/dl /repeated on another architect c8000=2.11 mg/dl laboratory reference range for 0 up to 12yrs=0.20 to 0.70 mg/dl; 12 yrs up to unspecified female=0.50 to 1.10 mg/dl; male=0.50 to 1.30 mg/dl.There was no reported impact to patient management.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) inspected the instrument, determined the worn bellows set, incl rod & fitting (rohs) (2-89055-02), the leaking manifold, degasser-wash sol.Pu (rohs) (7-93369-01) and clogged valve, reagent / sample, ckd (rohs) (7-202518-01) are the likely cause of the issue.The fsr replaced the bellows, cleaned/ tightened the other parts and the issues were resolved.A review of the architect c8000 serial number, (b)(6) service history was performed and no additional discrepant result issues have been reported since the service activity was completed.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 historical data revealed no trends, systemic issues, or related nonconformances 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 bellows set, incl rod & fitting (rohs) (2-89055-02), manifold, degasser-wash sol.Pu (rohs) (7-93369-01) and the valve, reagent / sample, ckd (rohs) (7-202518-01).A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for either the architect c8000 serial number, (b)(6), or the bellows set, incl rod & fitting (rohs), manifold, degasser-wash sol.Pu and the valve, reagent / sample.
Event or Problem Description
The customer observed discrepant results generated from architect c8000 processing module for several patients.The one result example provided were: sid (b)(6) creatinine initial=1.65 mg/dl /repeated on another architect c8000=2.11 mg/dl laboratory reference range for 0 up to 12yrs=0.20 to 0.70 mg/dl; 12 yrs up to unspecified female=0.50 to 1.10 mg/dl; male=0.50 to 1.30 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: 23136537
• Report Number: 3016438761-2025-00552
• Device Sequence Number: 9917163
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 09/05/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2011
• 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