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	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete information for section a patient information, 1.Patient identifier = sid= (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated potassium results generated from architect c16000 processing module for multiple patients.The results provided were: patient 1: sid (b)(6) initial=7.08 mmol/l /repeated on blood gas analyzer=4.7 mmol/l.Patient 2: sid (b)(6) initial=6.6 mmol/l /repeated on architect (b)(6) =3.5 mmol/l /repeated on blood gas analyzer=3.6 mmol/l.Laboratory reference range for potassium=3.5 to 5.2 mmol/l there was no reported impact to patient management.
Event or Problem Description
The customer observed falsely elevated potassium results generated from architect c16000 processing module for multiple patients.The results provided were: patient 1: sid (b)(6) initial=7.08 mmol/l /repeated on blood gas analyzer=4.7 mmol/l patient 2: sid (b)(6) initial=6.6 mmol/l /repeated on architect c1601435=3.5 mmol/l /repeated on blood gas analyzer=3.6 mmol/l laboratory reference range for potassium=3.5 to 5.2 mmol/l there was no reported impact to patient management.
Additional Manufacturer Narrative
The field service representative (fsr) inspected and replaced the tubing, peristaltic head (rohs) (7-35009685-04), which resolved the issue.A review of the architect c16000 processing module, serial number (b)(6)service history found revealed no additional service tickets associated with falsely elevated potassium patient results after service intervention.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 review of complaint and trending data associated with the architect tubing, peristaltic head did not identify an increase in complaint activity.The architect system operations manual addresses operational precautions and limitations and troubleshooting erratic/discrepant results.The architect c16000 system service and support manual provides removal and replacement procedures for the tubing, peristaltic head.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 c16000 processing module, serial number (b)(6), or the tubing, peristaltic head (rohs).

• 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: 21977980
• Report Number: 3016438761-2025-00268
• Device Sequence Number: 18438850
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2012
• 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: CONC ICT DILUENT, 02P32-50,; CONC ICT DILUENT, 02P32-50,
• Patient Sex: Unknown