MAUDE Adverse Event Report: UPDOC UPDOC COMMUNICATION PLATFORM; CALCULATOR, DRUG DOSE

Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Software version context: recent software modifications introducing artificial intelligence (al) modules.This report targets a critical software performance failure where the rapid deployment of an unregulated artificial intelligence (al) update has disabled foundational clinical safety infrastructure.Following a live software modification on (b)(6) 2026, the vital integration link that allows amazing charts ehr users to open updox was completely broken.Updox functions as our primary clinical system for patient secure messaging, receiving external lab/imaging diagnostic results, and interprofessional clinical data exchange.Because of this specific software failure, physicians can no longer open updox through the ehr.This completely blocks the communication pathway between our saginaw rheumatology practice, our patients, and external healthcare entities.Rheumatology workflows rely heavily on tight clinical monitoring for immunosuppressed patients on high-risk biologic regimens.This total breakdown in the communication interface introduces an immediate risk of unmanaged medication toxicities, delays critical lab reporting, and prevents timely interventions during patient disease flares.The deployment of clinical al features should not be permitted to break or disable core legacy communication infrastructure essential for daily patient safety.Actions requested by fda: we request that the fda review this software performance failure as a significant clinical safety risk caused by unmitigated al product deployment, and mandate that the developer provide an immediate hotfix to restore baseline communication systems.

• Brand Name: UPDOC COMMUNICATION PLATFORM
• Common Device Name: CALCULATOR, DRUG DOSE
• Manufacturer (Section D): UPDOC
• MDR Report Key: 25652535
• Report Number: MW5189965
• Device Sequence Number: 12171979
• Product Code: NDC
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2026

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
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/29/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown