MAUDE Adverse Event Report: ABBOTT LABORATORIES ARCHITECT C4000 PROCESSING MODULE (INTEGRATED); ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number	02P24-40
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated magnesium results from alinity c processing module on multiple patients.The results provided were: on (b)(6) 2026 sid (b)(6): 59yrs old female: initial=7.5 mg/dl /repeated=1.5mg/dl.On (b)(6) 2026 sid (b)(6): 80yrs old male: initial=6.9 mg/dl /repeated=1.8 mg/dl.Customer reference range for magnesium=1.6 to 2.6 mg/dl; critical range=< 1.0 or > 5.0 mg/dl.There was no reported impact to patient management.
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.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
During the requested site visit, the field service engineer (fse) inspected the instrument, performed troubleshooting procedures and determined the obstructed pump, probe wash, bellows type (rohs).The replacement of the pump, probe wash, bellows type (rohs), which resolved the issue.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 historical data revealed no trends, systemic issues, or related nonconformances.The architect system operations manual addresses operational precautions and limitations and troubleshooting of the fluidics subsystem and component replacement, removal and verification of the pump, probe wash, bellows type (rohs).A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation no product deficiency was identified for either the architect c4000 serial number (b)(6), or the pump, probe wash, bellows type (rohs).
Event or Problem Description
The customer observed falsely elevated magnesium results from alinity c processing module on multiple patients.The results provided were: on (b)(6) 2026 sid (b)(6): 59 yrs old female: initial=7.5 mg/dl /repeated=1.5mg/dl.On (b)(6) 2026 sid (b)(6): 80 yrs old male: initial=6.9 mg/dl /repeated=1.8 mg/dl.Customer reference range for magnesium=1.6 to 2.6 mg/dl; critical range=< 1.0 or > 5.0 mg/dl.There was no reported impact to patient management.

• Brand Name: ARCHITECT C4000 PROCESSING MODULE (INTEGRATED)
• 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: 24755285
• Report Number: 3016438761-2026-00183
• Device Sequence Number: 15646319
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 02P24-40
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CC MAGNESIUM (1000T), 03P68-24, 77641UD00; CC MAGNESIUM (1000T), 03P68-24, 77641UD00
• Patient Sex: Unknown