FDA 483 - Infinium Medical, Inc - November 08, 2023

During an FDA inspection conducted from November 7-8, 2023, Infinium Medical, Inc., a medical device manufacturer, received a Form FDA-483 citing two key observations regarding its quality system. These observations primarily relate to the company's handling of device malfunctions and subsequent reporting responsibilities, falling under the regulatory framework that governs medical device oversight.

The first observation noted that service reports indicating potential adverse events, which should be escalated to formal complaints, were not processed in accordance with 21 CFR 820.198. A specific example involved an OMNI K Monitor malfunction during patient oral surgery that was not reclassified as a complaint, despite the company's internal procedures requiring such escalation for events that could lead to death or serious injury if repeated.

The second observation highlighted a failure to submit a Medical Device Report (MDR) within 30 days of learning about a device malfunction that could cause or contribute to a death or serious injury upon recurrence. This directly pertained to the OMNI K Monitor incident, where the device "went white" during surgery due to a component failure.

Infinium Medical, Inc. is required to address these deficiencies by implementing corrective actions to ensure proper complaint handling and timely submission of MDRs, thereby aligning with federal regulations. The company has committed to correcting both observations.