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	01/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed potassium on the architect c4000 processing module for a 62-year-old female taking a potent neuroleptic medication.The patient sample was repeated on the blood gas analyzer with a higher result.The following results were provided (reference range 3.4 - 5.1 mmol/l): sid (b)(6), initial potassium result= 1.5 mmol/l, which was confirmed by a second blood draw; the sample was test at another facility with the same results; repeat results on the blood gas analysis (capillary blood draw) = 4 mmol/l.The patient was retested on (b)(6) 2026 with a result of 2.5 mmol/l.The patient received iv potassium.The customer confirmed the iv potassium the patient received wasn't considered unnecessary.There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Section d10 - concomitant product: this section was updated from blank to ict sample diluent (ln 02p32-50) lot 35857un25.This report is being filed on an international product, list number 02p24-40, that has the same product distributed in the us, list number 02p24-40, that is 510k exempt.The ict sample diluent is used for analysis of electrolytes on the architect c4000 processing module.A search for similar complaints did not identify an increase in complaint activity for lot 35857un25.A review of tracking and trending for the ict sample diluent (list number 02p32) did not identify any related trends.The device history review did not identify any nonconformances, potential nonconformance or deviations associated with lot 35857un25 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect c4000 processing module for serial (b)(6) or the ict sample diluent, lot number 35857un25, was identified.
Event or Problem Description
The customer observed falsely depressed potassium on the architect c4000 processing module for a 62-year-old female taking a potent neuroleptic medication.The patient sample was repeated on the blood gas analyzer with a higher result.The following results were provided (reference range 3.4 - 5.1 mmol/l): sid (b)(6), initial potassium result= 1.5 mmol/l, which was confirmed by a second blood draw; the sample was test at another facility with the same results; repeat results on the blood gas analysis (capillary blood draw)= 4 mmol/l.The patient was retested on (b)(6) 2026 with a result of 2.5 mmol/l.The patient received iv potassium.The customer confirmed the iv potassium the patient received wasn't considered unnecessary.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: 24153891
• Report Number: 3016438761-2026-00040
• Device Sequence Number: 21500086
• Product Code: JJE
• UDI-Device Identifier: 00380740003753
• UDI-Public: (01)00380740003753
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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: CONC ICT DILUENT, 02P32-50, 35857UN25.
• Patient Age: 62 YR
• Patient Sex: Female