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	12/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium result generated on a 89 years old male patient on the architect c16000.The following data was provided.(b)(6) 2025, sid (b)(6), initial result =3.35 mmol/l, repeat result from another instrument 0.94 mmol/l.The customer uses reference range 1.60 ¿ 2.60 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Complete information for section a1 - patient identifier: sid (b)(6).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed falsely elevated magnesium result generated on (b)(6) male patient on the architect c16000.The following data was provided.(b)(6) 2025, sid (b)(6), initial result =3.35 mmol/l, repeat result from another instrument 0.94 mmol/l.The customer uses reference range 1.60 ¿ 2.60 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
Concomitant information was updated for lot# 75412ud00 from 03p68-21 to 03p68-34.The field service representative (fsr) inspected the architect c16000 processing module, serial number (b)(6) and found a blockage in the waste line an hcw pump out to t ftg (rohs) tubing and cleared the clog.Removal of the clog from the hcw pump out to t ftg (rohs) resolved the issue.The instrument service history review revealed no additional service tickets associated with discrepant/erratic magnesium.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 tracking and trending did not identify any trends for the architect c16000 processing module with regards to the customer reported event.A review of trending data associated with the hcw pump out to t ftg (rohs) did not identify any trends.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 the investigation, no systemic issue or deficiency of the architect c16000 processing module, serial number (b)(6) or the hcw pump out to t ftg (rohs) were identified.

• 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: 23986171
• Report Number: 3016438761-2026-00011
• Device Sequence Number: 4630159
• Product Code: JJE
• UDI-Device Identifier: 00380740005924
• UDI-Public: (01)00380740005924
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/24/2026

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: 12/29/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2013
• 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 (3750T), 03P68-34, 75412UD00; CC MAGNESIUM 1000T, 03P68-21, 75412UD00; TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN; TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN
• Patient Age: 89 YR
• Patient Sex: Male