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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section e1 - phone number: (b)(6).Section a patient information: refer to section b5 for complete patient information.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 depressed architect calcium results generated on the architect c4000 instrument.The following data was provided: initial result 2 mg/dl, repeated normal (the value was not provided).Expected values: 9.0 - 10.2 mg/dl.No impact to patient management was reported.
Event or Problem Description
The customer observed falsely depressed architect calcium results generated on the architect c4000 instrument.The following data was provided: initial result 2 mg/dl, repeated normal (the value was not provided).Expected values: 9.0 - 10.2 mg/dl.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the architect c4000 processing module, serial number (b)(6) and observed the cuvette washer overflowing.Multiple parts were replaced to resolve the issue.Replacement of the sample probe, the c4/c8 rgt pr rohs, the sheet valve, and the diaphragm of the vacuum pump resolved the issue.The instrument service history review revealed no additional service or complaint issues associated with discrepant/erratic patient results.A review of complaint and trending data for the architect c4000 processing module and associated parts did not identify any trends with regards to the customers reported event.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling adequately addresses sample results observed problems for erratic / discrepant results based on the investigation, no systemic issue or deficiency was identified for the architect c4000 processing module, serial number (b)(6).

• 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: 24640033
• Report Number: 3016438761-2026-00147
• Device Sequence Number: 18588619
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/10/2026

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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2015
• 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: ARC CALCIUM2 KIT 5400T, 04S91-30, UNKNOWN.; ARC CALCIUM2 KIT 5400T, 04S91-30, UNKNOWN.
• Patient Sex: Unknown