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	03/18/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer observed falsely depressed calcium2 & falsely depressed glucose results on the architect c8000 processing module for multiple patients.Results were not reported to medical provider.The following example was provided.Calcium: initial result =3.5 mg/dl, repeat result =8.5 mg/dl.Sid (b)(6); 65 years old male, initial result= 3.7 mg/dl, repeat result = 9.0 mg/dl, repeat results from another processing module =9.1 mg/dl.Sid (b)(6); 87-year-old male; initial result= 3.1 mg/dl, repeat result =8.2 mg/dl.Customer reference range is (8.4 ¿ 10.4 mg/dl) glucose: (b)(6) 2026, sid (b)(6); 28 years old female; initial result = 33 mg/dl, repeat result= 78 mg/dl.The customer reference range: (70 ¿ 100 mg/dl).There was no impact to patient management reported.
Additional Manufacturer Narrative
During site visit by abbott field service (fsr), the architect c8000 processing module was inspected, and found the sample probe (01g48-04) misaligned and was not being properly washed.The fsr performed troubleshooting including realignment of the #1 mixer and the sample probe which resolved the issue.The instrument service history review revealed no additional service 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 of the architect c8000 processing module or the sample probe, did not identify elevated complaint issue.The architect system operations manual provides adequate information regarding troubleshooting, and the removal, replacement, and verification of sample probe.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 processing module, serial number (b)(6), or the sample probe.

• 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: 24799870
• Report Number: 3016438761-2026-00201
• Device Sequence Number: 9620479
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 04/20/2026

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: 03/19/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CC CALCIUM(11440T), 03L79-32, 60381UN25; CC CALCIUM(11440T), 03L79-32, 60381UN25; CC GLUCOSE(15000T), 03L82-42, 68822UQ07; CC GLUCOSE(15000T), 03L82-42, 68822UQ07
• Patient Sex: Unknown