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	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information.Section e1 phone number complete information: (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 falsely elevated calcium2 results generated on the architect c4000 processing module for two patient samples.The following data was provided (customer¿s reference ranges at different facilities - architect 2.25¿2.55 mmol/l, alinity 2.1¿2.55 mmol/l): (b)(6) 2026, sample id (b)(6), (86-year-old female) initial result = 4.47 mmol/l, (b)(6) 2026 same sample was repeated on alinity analyzer at another laboratory and result = 2.35 mmol/l.(b)(6) 2026 sample id (b)(6) (77-year-old female) initial result = 5.18 mmol/l, repeat result = 5.26 mmol/l.(b)(6) 2026 new sample obtained and result on the radiometer = 1.16 mmol/l (b)(6) 2026 same sample was repeated on alinity analyzer at another laboratory and result = 2.36 mmol/l.No impact to patient management was reported.
Additional Manufacturer Narrative
The field service representative (fsr) inspected the instrument, performed trouble shooting and discovered an obstruction in the nozzle c4 #1, #4, #5 (rohs).The part was cleaned which resolved the issue.An instrument service history review for (b)(6) revealed no additional tickets associated with discrepant/erratic results.There were no additional service or complaint issues on or around the date this complaint was initiated that may have contributed to this issue.A review of complaint and trending data for the architect c4000 processing module did not identify any similar issues with regards to the customer reported event.Additionally, review of complaint and trending data associated with the nozzle c4 #1, #4, #5 (rohs) did not identify any trends.Review of the manufacturing documentation did not identify any non-conformances or potential non-conformances associated with 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, serial number (b)(6), or the nozzle c4 #1, #4, #5 (rohs) was identified.
Event or Problem Description
The customer observed falsely elevated calcium2 results generated on the architect c4000 processing module for two patient samples.The following data was provided (customer¿s reference ranges at different facilities - architect 2.25¿2.55 mmol/l, alinity 2.1¿2.55 mmol/l): (b)(6) 2026 sample id (b)(6), (86-year-old female) initial result = 4.47 mmol/l, (b)(6) 2026 same sample was repeated on alinity analyzer at another laboratory and result = 2.35 mmol/l.(b)(6) 2026 sample id (b)(6), (77-year-old female) initial result = 5.18 mmol/l, repeat result = 5.26 mmol/l.(b)(6) 2026 new sample obtained and result on the radiometer = 1.16 mmol/l.(b)(6) 2026 same sample was repeated on alinity analyzer at another laboratory and result = 2.36 mmol/l.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: 24402603
• Report Number: 3016438761-2026-00101
• Device Sequence Number: 8223215
• 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): 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): 03/13/2026

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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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 1200T, 04S91-20, 79147UD00; ARC CALCIUM2 KIT 1200T, 04S91-20, 79147UD00; NOZZLE C4 #1, #4, #5 (ROHS), 7-205228-02, UNKNOWN; NOZZLE C4 #1, #4, #5 (ROHS), 7-205228-02, UNKNOWN
• Patient Sex: Female