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	10/18/2025
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.
Event or Problem Description
The customer observed falsely elevated magnesium on the architect c4000 processing module for one patient.The following results were provided: customer¿s reference range 1.6-2.6 mg/dl on (b)(6) 2025, sid (b)(6), 72-year-old female, initial magnesium result= 4.95 mg/dl; repeat result= 1.09 mg/dl there was no impact to patient management reported.
Event or Problem Description
The customer observed falsely elevated magnesium on the architect c4000 processing module for one patient.The following results were provided: customer¿s reference range 1.6-2.6 mg/dl.(b)(6) 2025, sid (b)(6), 72-year-old female, initial magnesium result= 4.95 mg/dl; repeat result= 1.09 mg/dl there was no impact to patient management reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument and found the arc c8k cuv pr 1 pair number 44 was chipped.The fsr replaced the part which resolved the issue.The module function was verified with a control/precision run.The instrument service history for the (b)(6) verified no subsequent issues have been reported related to the complaint issue after the service intervention.A review of tracking and trending of the arc c8k cuv pr 1 pair did not identify any trends.A review of tracking and trending did not identify any trends for the architect c4000 with regards to the current issue.A review of manufacturing documentation did not identify any non-conformances related to the complaint issue.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c4000 processing module or the arc c8k cuv pr 1 pair was identified.

• 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: 23512005
• Report Number: 3016438761-2025-00663
• Device Sequence Number: 21265669
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2020
• 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: 72 YR
• Patient Sex: Female