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	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
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.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed imprecise magnesium results generated on the architect c4000 instrument.The following data was provided: on (b)(6) 2026, for sid (b)(6), the initial magnesium result was 6.58 mg/dl (patient panel), the sample was repeated with other samples running and the result was 1.31 mg/dl.The sample was repeated with no other samples running and the result was 1.91 mg/dl (reported).On (b)(6) 2026, for sid (b)(6), the initial magnesium result was 0.94 mg/dl (patient panel), the sample was repeated with other samples running and the result was 4.25 mg/dl.The sample was repeated with no other samples running and the result was 3.97 mg/dl (reported).No impact to patient management was reported.
Additional Manufacturer Narrative
Troubleshooting of the architect c4000 processing module (integrated), (b)(6) performed by an abbott service representative included replacement of the nozzle, dry (rohs) which resolved the issue.The module function was verified with a control run.The service history of the architect c4000 processing module (integrated), (b)(6) returned no additional tickets for discrepant magnesium results after the service was completed.A review of tracking and trending data did not identify any trends related to the complaint issue.A review of the corrective and preventive actions system did not identify any nonconformances or deviations for the nozzle, dry (rohs).A review of the product labeling concluded that the issue is sufficiently addressed.The architect c4000 system service and support manual contains adequate information for the troubleshooting of the nozzle, dry (rohs) part replacement.Based on the investigation no systemic issue or product deficiency was identified.
Event or Problem Description
The customer observed imprecise magnesium results generated on the architect c4000 instrument.The following data was provided: on (b)(6) 2026, for sid (b)(6), the initial magnesium result was 6.58 mg/dl (patient panel), the sample was repeated with other samples running and the result was 1.31 mg/dl.The sample was repeated with no other samples running and the result was 1.91 mg/dl (reported).On (b)(6) 2026, for sid (b)(6), the initial magnesium result was 0.94 mg/dl (patient panel), the sample was repeated with other samples running and the result was 4.25 mg/dl.The sample was repeated with no other samples running and the result was 3.97 mg/dl (reported).No impact to patient management was 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: 24691201
• Report Number: 3016438761-2026-00161
• Device Sequence Number: 10004295
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• 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): 04/02/2026

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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2023
• 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, 77641UD00.; CC MAGNESIUM (1000T), 03P68-24, 77641UD00.
• Patient Sex: Unknown