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	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 reported that the front cover/door of the architect c4000 analyzer was observed to free fall when opened slightly.The customer identified that the cover did not hold its position and could drop unexpectedly.The door was subsequently adjusted to prevent further free fall.No injury to the user was reported.No impact to patient management was reported.
Additional Manufacturer Narrative
D10-concomittant product was updated from bellows set,incl rod & fitting (rohs), 2-89055-02, to hinge, front cover c4 (rohs), 7-207365-01.The field service representative inspected the instrument and determined the hinge, front cover c4 (rohs) (7-207365-01) was the likely cause of the issue, which was adjusted it to prevent injury to personnel.Part adjustment resolved the issue.The instrument service history review revealed no additional service or complaint issues on or around the date.A review of tracking and trending did not identify any trend for the hinge, front cover c4 (rohs) (7-207365-01).Review of the scorecard identified no similar issues related to the architect system or likely cause part as described.A review of historical data found no non-conformances related to the current complaint.Labeling was reviewed and provides adequate information regarding instructions for removal, replacement and adjustment of the hinge, front cover c4 (rohs) (7-207365-01) to ensure proper function.Based on the investigation, no systemic issue or deficiency for the architect c4000 processing module sn (b)(6) or hinge, front cover c4 (rohs) (7-207365-01) was identified.
Event or Problem Description
The customer reported that the front cover/door of the architect c4000 analyzer was observed to free fall when opened slightly.The customer identified that the cover did not hold its position and could drop unexpectedly.The door was subsequently adjusted to prevent further free fall.No injury to the user was reported.No impact to patient management was reported.

• 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 ; 6122582960
• MDR Report Key: 24370004
• Report Number: 3016438761-2026-00094
• Device Sequence Number: 20036861
• Product Code: JJE
• UDI-Device Identifier: 00380740003746
• UDI-Public: (01)00380740003746
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 03/16/2026

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: 02/04/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2023
• 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: BELLOWS SET,INCL ROD & FITTING (ROHS), 2-89055-02,; HINGE, FRONT COVER C4 (ROHS), 7-207365-01,
• Patient Sex: Unknown