MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C8000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	01G06-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
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.This report is being filed on an international product, list number 1g06-01 that has a similar product distributed in the us, list number 1g06-11/-98.A1 patient identifier: complete sample id is (b)(6).
Event or Problem Description
The customer reported falsely elevated potassium results generated on the architect c8000 processing module for one sample.The following data was provided: sid (b)(6): initial report = 6.5 mmol/l, repeat = 4.8 mmol/l.Per the customer discrepant results were not reported out to the medical provider.No impact to patient management was reported.
Additional Manufacturer Narrative
The customer reported observing a falsely elevated potassium result with the ict sample diluent.As part of troubleshooting, the customer reran the sample using the same ict sample diluent and generated the expected result.Quality controls were within range at the time of the incident.A search by product did not identify an increase in complaint activity related to the issue under review.A review of tracking and trending for the ict sample diluent did not identify any trends related to the complaint issue.Device history review did not identify any nonconformances or deviations associated with the complaint issue.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of the architect c8000 processing module, serial number (b)(6) or the ict sample diluent was identified.
Event or Problem Description
The customer reported falsely elevated potassium results generated on the architect c8000 processing module for one sample.The following data was provided: sid (b)(6): initial report = 6.5 mmol/l, repeat = 4.8 mmol/l.Per the customer discrepant results were not reported out to the medical provider.No impact to patient management was reported.

• 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: 23413712
• Report Number: 3016438761-2025-00642
• Device Sequence Number: 10408243
• Product Code: JJE
• UDI-Device Identifier: 00380740023089
• UDI-Public: (01)00380740023089
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 01G06-01
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: CONC ICT DILUENT, 02P32-11, UNKNOWN; CONC ICT DILUENT, 02P32-11, UNKNOWN
• Patient Sex: Unknown