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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for a1 - patient identifier: sid (b)(6).An evaluation is in process.A final 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 discrepant patient results for multiple assays for 2 patients when processed on the architect analyzer.Results were not reported to medial provider.The following data provided.Sid (b)(6).Calcium, initial result = 4.6 mg/dl, repeat result = 9.1 mg/dl, reference range= 8.5 ¿ 10.5 mg/dl.Co2, initial result = 5 mmol/l, repeat result = 23 mmol/l, reference range= 20 ¿ 31 mmol/l glucose, initial result = 20 mg/dl, repeat result = 101 mg/dl, reference range= 70 ¿ 100 mg/dl.Sodium, initial result = 110 mmol/l, repeat result = 140 mmol/l, reference range= 135 ¿ 145 mmol/l.Sid (b)(6) calcium, initial result = 5.8 mg/dl, repeat result = 9.2 mg/dl, reference range= 8.5 ¿ 10.5 mg/dl.There was no impact to patient management reported.
Additional Manufacturer Narrative
The instrument was inspected, and the cc cuv dry tip was replaced, the diaphragm, vacuum pump new style (rohs) was rebuilt, and the cuvettes were manually washed to resolve the issue.The cc cuv dry tip and diaphragm, vacuum pump new style (rohs) were determined to be the cause of the issue.The instrument architect c4000 processing module, serial number (b)(6) service history review revealed no additional tickets associated with discrepant/erratic patient results.A service history found no contributing factors on or around the date of the complaint.A review of tracking and trending of the architect c4000 processing module or the parts, did not identify any trends associated with the complaint issue.A review of historical data revealed no trends, systemic issues, or related nonconformances.The architect system operations manual addresses operational precautions and limitations and troubleshooting of the fluidics subsystem.The architect c4000 system service and support manual provides removal and replacement procedures for the diaphragm, vacuum pump new style and cc cuv dry tip.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.Based on the investigation, no product deficiency was identified for the architect c4000 processing module, serial number (b)(6), or the diaphragm, vacuum pump new style.
Event or Problem Description
The customer observed discrepant patient results for multiple assays for 2 patients when processed on the architect analyzer.Results were not reported to medial provider.The following data provided.Sid (b)(6): calcium, initial result = 4.6 mg/dl, repeat result = 9.1 mg/dl, reference range= 8.5 ¿ 10.5 mg/dl.Co2, initial result = 5 mmol/l, repeat result = 23 mmol/l, reference range= 20 ¿ 31 mmol/l.Glucose, initial result = 20 mg/dl, repeat result = 101 mg/dl, reference range= 70 ¿ 100 mg/dl.Sodium, initial result = 110 mmol/l, repeat result = 140 mmol/l, reference range= 135 ¿ 145 mmol/l.Sid (b)(6): sodium, initial result = 103 mmol/l, repeat result = 132 mmol/l, reference range= 135 ¿ 145 mmol/l.Calcium, initial result = 5.8 mg/dl, repeat result = 9.2 mg/dl, reference range= 8.5 ¿ 10.5 mg/dl.There was no impact to patient management 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: 24245738
• Report Number: 3016438761-2026-00061
• Device Sequence Number: 20914635
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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,Followup
• Report Date (Section B): 03/12/2026

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: 01/15/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CC CALCIUM(11440T), 03L79-32, 27341UN25.; CC CO2(1500T), 03L80-22, 68074UQ03.; CC GLUCOSE(1500T), 03L82-22, 68512UQ06.
• Patient Sex: Unknown