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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported getting discrepant calcium results generated from architect c8000.The customer provided the following data: the first sample initial result was 4.9, and repeat was 8.7.The first sample initial result was 5.8, and repeat was 9.1.Reference range 8.4-10.2 mg/dl.Customer stated the results were not filed to patient charts.Per the customer the discrepant results were not reported out to the patient¿s 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
Abbott service inspected the architect c8000 processing module (b)(6) and performed troubleshooting.Cleaning of the nozzle # 5 of the washer, cuvette resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tickets identified no contributing factors to this complaint.A trend review found no elevated complaint activity for the architect c8000 processing module or the washer, cuvette.A review of historical data with this complaint revealed no systemic issues, or nonconformances.Manufacturing documentation for the did not identify any issues associated with the complaint issue.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the architect c8000 processing module and the washer, cuvette.
Event or Problem Description
The customer reported getting discrepant calcium resutls generated from architect c8000.The customer provided the following data: the first sample initial result was 4.9, and repeat was 8.7.The first sample initial result was 5.8, and repeat was 9.1.Reference range 8.4-10.2 mg/dl.Customer stated the results were not filed to patient charts.Per the customer the discrepant results were not reported out to the patient¿s 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: 22899207
• Report Number: 3016438761-2025-00498
• Device Sequence Number: 14948977
• Product Code: JJE
• UDI-Device Identifier: 00380740000509
• UDI-Public: (01)00380740000509
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/02/2025

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: 08/06/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2010
• 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 CALCIUM (11440T), 03L79-32, 35491UN24.; CC CALCIUM (11440T), 03L79-32, 35491UN24.
• Patient Sex: Unknown