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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
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.E1 - postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field.This issue was previously reported under mdr number 3005094123-2025-00242 under a different suspect device.
Event or Problem Description
The customer observed imprecise magnesium results generated on the architect c16000 processing module.The following data was provided (customer¿s reference range: 0.61-1.03 mmol/l): initial result = 1.02 mmol/l; repeat result = 0.52 mmol/l there was no impact to patient management reported.
Event or Problem Description
The customer observed imprecise magnesium results generated on the architect c16000 processing module.The following data was provided (customer¿s reference range: 0.61-1.03 mmol/l): initial result = 1.02 mmol/l; repeat result = 0.52 mmol/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The technical service specialist (tss) inspected the architect c16000 processing module, serial number (b)(6), and resolved the issue by rebuilding the vacuum pump and replacing the cuvette dry tip and bulk solution valve assembly.No additional discrepant result issues have been reported since the service activity was completed.A definitive cause of the discrepant results was not identified.The instrument service history review revealed no additional service 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 c16000 processing module did not identify an increase in complaint activity related to the current complaint issue.A review of the device history record did not identify any nonconformances or deviations related to the complaint issue.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 d10- concomitant product: removed cc cuv dry tip, 09d51-02, unknown.

• 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: 22080625
• Report Number: 3016438761-2025-00314
• Device Sequence Number: 9338035
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 06/16/2025

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: 05/21/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2014
• 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: CC CUV DRY TIP, 09D51-02, UNKNOWN; CC MAGNESIUM (3750T), 03P68-34, 71411UD00; CC MAGNESIUM (3750T), 03P68-34, 71411UD00
• Patient Sex: Unknown