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	03/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated creatinine result for one patient on an architect c16000 analyzer.The following data was provided (customer¿s reference range is 59-104 umol/l): initial result was 1437.92, repeat result was 57.98 umol/l there was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and observed the peristaltic head tubing leaking.The part was replaced, and the issue was resolved.A review of instrument service history for serial number (b)(6) revealed that no additional discrepant result issues have been reported since the service activity was completed.There were no service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect c16000 processing module did not identify an increase in complaint activity associated with the complaint issue.Additionally, a review of complaint and trending data associated with the peristaltic head tubing did not identify any trends.A review of the manufacturing documentation did not identify any non-conformances associated with the complaint issue.Labeling was reviewed and found to be adequate.Based on the investigation, no systemic issue or deficiency was identified for the architect c16000 processing module, serial number (b)(6), or the peristaltic head tubing.
Event or Problem Description
The customer observed a falsely elevated creatinine result for one patient on an architect c16000 analyzer.The following data was provided (customer¿s reference range is 59-104 umol/l): initial result was 1437.92, repeat result was 57.98 umol/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: 24746260
• Report Number: 3016438761-2026-00180
• Device Sequence Number: 12954942
• 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): 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): 04/06/2026

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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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: BIOSINO CREAT ENZY II B, 09P02-20, (B)(6).; BIOSINO CREAT ENZY II B, 09P02-20, (B)(6).
• Patient Sex: Unknown