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	07/04/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated creatinine result for one patient sample when using the multigent enzymatic creatinine assay on the architect c16000 processing module.The following data was provided (customer¿s normal ranges for creatinine: man = 64-104 umol/l and female = 49-90 umol/l): initial creatinine result = 1780 umol/l repeat creatinine result = 41 umol/l.There was no impact to patient management reported.
Event or Problem Description
The customer reported a falsely elevated creatinine result for one patient sample when using the multigent enzymatic creatinine assay on the architect c16000 processing module.The following data was provided (customer¿s normal ranges for creatinine: man = 64-104 umol/l and female = 49-90 umol/l): initial creatinine result = 1780 umol/l.Repeat creatinine result = 41 umol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The architect c16000 processing module, serial number (b)(6), was inspected, and multiple troubleshooting procedures were performed including part replacement, however, a definitive part was not identified as the likely cause for the issue.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.A review of complaint and trending data for the architect c processing module did not identify an increase in complaint activity associated with the complaint issue.A review of manufacturing data for the architect c16000 did not identify any nonconformances or deviations.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency of the architect c16000 processing module, serial number (b)(6), was identified.Updated h4 - device mfg date :(b)(6) 2017.

• 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: 22527632
• Report Number: 3016438761-2025-00410
• Device Sequence Number: 8736507
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/05/2025

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: 07/10/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/16/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2017
• 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: MLTGNT ENZY CREAT, 08L24-41, 50500Y600; MLTGNT ENZY CREAT, 08L24-41, 50500Y600
• Patient Sex: Unknown