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	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely decreased results generated from architect c8000.The customer provided the following data: creatinine result was 1.38 mg/dl and when repeated on another analyzer the result was 3.99 mg/dl.Previous result was 4.39 mg/dl.Customer normal range 0.72--1.25 mg/dl glucose initial result was <6 and repeat result was 120 (customer normal range: 70-105 mg/dl).Per the customer discrepant results were not reported out to the medical provider.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.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and observed the rgt syr o-rng on top of the r2 syringe block was broken.The fsr replaced the rgt syr o-rng which resolve the issue.Additionally, the sample, r1 and r2 seal tips and o-rings were also replaced.No additional discrepant result issues have been reported since the service activity was completed.The instrument service history review for (b)(6) revealed no additional tickets associated with discrepant/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 tracking and trending for the rgt syr o-rng did not identify any trends.A review of tracking and trending for the architect c8000 did not identify any similar issues related to the complaint issue.A review of manufacturing documentation did not identify any non-conformances related to the complaint issue.The architect system operations manual provides adequate information regarding the troubleshooting of erratic/discrepant results and instruction for the removal, replacement, and verification of the rgt syr o-rng.Based on the available information, no systemic issue or deficiency of the architect c8000 processing module, serial (b)(6) or the rgt syr o-rng was identified.
Event or Problem Description
The customer reported falsely decreased results generated from architect c8000.The customer provided the following data: creatinine result was 1.38 mg/dl and when repeated on another analyzer the result was 3.99 mg/dl.Previous result was 4.39 mg/dl.Customer normal range 0.72--1.25 mg/dl glucose initial result was <6 and repeat result was 120 (customer normal range: 70-105 mg/dl) per the customer discrepant results were not reported out to the medical provider.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: 23848131
• Report Number: 3016438761-2025-00741
• Device Sequence Number: 18527623
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/09/2026

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: 12/01/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2014
• 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 GLUCOSE(1500T), 03L82-22, 68169UQ04; CC GLUCOSE(1500T), 03L82-22, 68169UQ04; MLTGNT ENZY CREAT 750T, 08L24-31, 14446UN25; MLTGNT ENZY CREAT 750T, 08L24-31, 14446UN25
• Patient Sex: Unknown