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	04/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6) an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated potassium results generated on the alinity c processing module for a 66-year-old male patient.The following results were provided: (customer provided reference range is 3.5-5.2 mmol/l) sid (b)(6) initial result = 6.50 mmol/l, repeat result = 4.9 mmol/l no impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated potassium results generated on the architect c16000 processing module for a 66-year-old male patient.The following results were provided: (customer provided reference range is 3.5-5.2 mmol/l).Sid (b)(6) initial result = 6.50 mmol/l, repeat result = 4.9 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Correction in section b5: corrected typographical error of alinity c to architect c16000.The field service representative inspected the architect c16000 processing module, performed troubleshooting procedures, found there were bubbles in the 1ml syringe and replaced the part.Part replacement resolved the issue.No additional discrepant result issues have been reported since the service activity was completed.The instrument service history review revealed no additional 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.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.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 1ml syringe did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any nonconformance or potential nonconformance related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c16000 processing module for serial number (b)(6) or 1ml syringe was identified.All available patient information was included.Additional patient details are not available.

• 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: 24909542
• Report Number: 3016438761-2026-00220
• Device Sequence Number: 9874665
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• 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): 04/30/2026

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: 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: 04/11/2026
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2020
• 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: 1ML SYRINGE, 09D41-03, UNKNOWN; 1ML SYRINGE, 09D41-03, UNKNOWN
• Patient Age: 66 YR
• Patient Sex: Male