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	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 - patient identifier: complete sample id is (b)(6).This report is being filed on an international product, list number 02p24-40, that has the same product distributed in the us, list number 02p24-40, that is 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated magnesium on the architect c4000 processing module for one patient.The following results were provided (reference range 1.6 - 2.6 mg/dl): (b)(6) 2025, sid (b)(6), initial magnesium result= 2.40 mg/dl; (b)(6) 2025, repeat result= 6.93 mg/dl.The patient is a 34-year-old female there was no impact to patient management reported.
Additional Manufacturer Narrative
The technical service specialist (tss) inspected the architect c4000 processing module, serial number (b)(6), and replaced the sample probe and mixer 1.Replacement of the sample probe and mixer 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 tracking and trending did not identify any trends for the architect c4000 processing module with regards to the customer reported event.A review of trending data associated with the sample probe and mixer 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 c4000 processing module, serial number (b)(6) or the sample probe and mixer were identified.
Event or Problem Description
The customer observed a falsely elevated magnesium on the architect c4000 processing module for one patient.The following results were provided (reference range 1.6 - 2.6 mg/dl): (b)(6) 2025, sid (b)(6), initial magnesium result= 2.40 mg/dl; (b)(6) 2025, repeat result= 6.93 mg/dl the patient is a 34-year-old female there was no impact to patient management reported.

• 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: 23849099
• Report Number: 3016438761-2025-00743
• Device Sequence Number: 15911638
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 01/19/2026

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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2017
• 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: CC MAGNESIUM (1000T), 03P68-24, UNKNOWN; CC MAGNESIUM (1000T), 03P68-24, UNKNOWN
• Patient Age: 34 YR
• Patient Sex: Female