FDA 483 - Medtronic Puerto Rico Operations Co. - February 17, 2017

During an inspection conducted by the Food and Drug Administration (FDA) from January 30 to February 17, 2017, the inspected firm received a Form FDA 483. The document highlighted significant issues concerning complaint handling for its Paradigm Insulin Pumps, models 523/723. The inspection revealed that over a 12-month period in 2016, there were numerous reported complaints related to these insulin pumps, some of which resulted in Medical Device Reports (MDRs). Despite the volume of complaints, the firm conducted only 13 Device History Record (DHR) reviews during the same timeframe and failed to initiate formal investigations for these reported issues. This indicates a potential deviation from regulatory requirements for complaint handling and investigation processes, crucial for ensuring device safety and compliance with FDA's Quality System Regulation. The firm acknowledged two observations, noting a promise to correct them. These required actions emphasize the need for the company to establish and adhere to robust procedures for complaint intake, evaluation, and investigation, ensuring that all complaints, especially those leading to MDRs, are thoroughly addressed to prevent recurrence and protect public health.