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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely decreased calcium result generated on the architect c4000 processing module for one sample.The following results were provided: (customer provided calcium reference range: 8.1-10.0 mg/dl).Sid (b)(6), 74-year-old female patient: calcium result = 5.8 mmol/l, repeat result = 9.2 mg/dl.No impact to patient management was reported.
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.

• 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 ; +49()6122582960
• MDR Report Key: 50947903
• Report Number: 3016438761-2026-00544
• Device Sequence Number: 18753518
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 02P24-01
• 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: 09/13/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 74 YR
• Patient Sex: Female