MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C16000 PROCESSING MODULE; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	03L77-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated potassium result generated by the architect c16000 processing module for a patient.The sample was repeated, and a lower result was obtained.The following data was provided: customer¿s normal range: 3.5 to 5.0 mmol/l.Sid: (b)(6) initial result = 9.1 mmol/l; repeat result = 4.9 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
Section a1: patient identifier: complete sample id is (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
The customer support specialist advised the customer to recalibrate the reagent probe (r1a) and clean the mixers.The customer performed these procedures and the issue was resolved.The reagent probe was determined to be the likely cause of the result issue.An instrument service history review for c1601804 revealed no additional service ticket associated with discrepant or erratic patient results.A review of complaint and trending data for the architect c16000 processing module did not identify any similar issues as described in this complaint.Additionally, a review of complaint and trending data associated with the reagent probe did not identify an increase in complaint activity.The device history record was reviewed, and no non-conformances or potential non-conformances were identified.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency of the architect c16000 processing module, serial number (b)(6), or the reagent probe was identified.
Event or Problem Description
The customer observed a falsely elevated potassium result generated by the architect c16000 processing module for a patient.The sample was repeated, and a lower result was obtained.The following data was provided: customer¿s normal range: 3.5 to 5.0 mmol/l.Sid (b)(6) initial result = 9.1 mmol/l; repeat result = 4.9 mmol/l.There was no impact to patient management reported.

• Brand Name: ARCHITECT C16000 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: 21966935
• Report Number: 3016438761-2025-00264
• Device Sequence Number: 8123068
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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): 05/15/2025

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: 03L77-01
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2018
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONC ICT DILUENT, 02P32-50, (B)(6) ; CONC ICT DILUENT, 02P32-50, (B)(6)
• Patient Sex: Unknown