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	11/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed elevated magnesium results when processing on the architect c16000 processing module.Sid (b)(6), initial result 3.6 (not reported out of the lab), repeated on another analyzer of 0.77, 0.82.No unit of measure was provided.No impact to patient management was reported.
Additional Manufacturer Narrative
Section a patient information: no additional patient information was provided.An evaluation is in process.A followup report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Additional information is section a patient information, patient age and patient sex updated.Additional patient information is unknown.Section b5 describe event or problem updated.The evaluation is in process.A followup report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed elevated magnesium results when processing on the architect c16000 processing module.Sid (b)(6) initial result 3.6 (not reported out of the lab), repeated on another analyzer of 0.77, 0.82 mmol/l.No impact to patient management was reported.Additional information provided on 11dec2025: the customer uses a magnesium normal range of 0.66 to 1.07 mmol/l.
Additional Manufacturer Narrative
A complaint investigation was conducted for the architect c16000, serial number (b)(6).The field service representative (fsr) replaced the tubing, peristaltic head (rohs) and cleaned the tbg, h.C.Nozzle a (rohs), however, the tbg, h.C.Nozzle a (rohs) was deemed the cause for the module generating the false elevated magnesium patient results due to the part being clogged.The tbg, h.C.Nozzle a (rohs) was cleaned to resolve the issue.The instrument service history for the architect c16000, serial number (b)(6) verifies no subsequent issues have been reported related to false elevated magnesium patient results after service intervention.A review of tracking and trending did not identify any trends with regards to the customer reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on our investigation, no systemic issue or deficiency was identified for the architect c16000, serial number (b)(6) or the tbg, h.C.Nozzle a (rohs).
Event or Problem Description
The customer observed elevated magnesium results when processing on the architect c16000 processing module.Sid (b)(6), initial result 3.6 (not reported out of the lab), repeated on another analyzer of 0.77, 0.82 mmol/l.No impact to patient management was reported.Additional information provided on (b)(6) 2025: the customer uses a magnesium normal range of 0.66 to 1.07 mmol/l.

• 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: 23771150
• Report Number: 3016438761-2025-00714
• Device Sequence Number: 9722722
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 01/14/2026

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: 11/29/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 01/12/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/17/2025; 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2014
• 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 MAGNESIUM (1000T), 03P68-24, 77641UD00.; CC MAGNESIUM (1000T), 03P68-24, 77641UD00.; CC MAGNESIUM (1000T), 03P68-24, 77641UD00.
• Patient Age: 67 YR
• Patient Sex: Female