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

Catalog Number	02P24-01
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
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.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for one sample.The following results were provided: (normal patient range 1.6 ¿ 2.6 mg/dl) initial 7.5 mg/dl, repeat result = 1.7 mg/dl no impact to patient management was reported.
Event or Problem Description
The customer observed falsely elevated magnesium results generated on the architect c4000 processing module for one sample.The following results were provided: (normal patient range 1.6 ¿ 2.6 mg/dl) initial 7.5 mg/dl, repeat result = 1.7 mg/dl no impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) replaced the tubing, peristaltic head (rohs) of the architect c4000 processing module as the part was due to be replaced and deemed the likely cause.The architect c4000 processing module function was verified with a control/precision run.The instrument service history for the architect c4000 processing module serial number (b)(6) verifies no subsequent issues have been reported related to false elevated magnesium patient results or qc out of range after service intervention.Data and information provided by the customer were reviewed and support the complaint issue.A review of complaint and trending data for the architect c4000 processing module did not identify any similar issues related to the current issue.Additionally review of complaint and trending data associated with the tubing, peristaltic head (rohs) did not identify an increase in complaint activity.A review of the manufacturing documentation did not identify any nonconformances or potential nonconformances.Labeling was reviewed and found to be adequate.Based on the available information, no systemic issue or deficiency of the architect c4000 processing module for serial number (b)(6) was identified.All available patient information was included.Additional patient details are not available.

• Brand Name: ARCHITECT C4000 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: 21504039
• Report Number: 3016438761-2025-00127
• Device Sequence Number: 8006736
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/07/2025

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: 02P24-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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, 64202UD00; CC MAGNESIUM (1000T), 03P68-24, 64202UD00; TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN; TUBING, PERISTALTIC HEAD (ROHS), 7-35009685-04, UN
• Patient Sex: Unknown