FDA 483 - Medtronic Puerto Rico Operations Co. - August 29, 2017

An unnamed medical device firm was inspected by the FDA from August 16 to August 29, 2017, resulting in a Form FDA-483 observation. The primary issue identified was the inadequacy of established procedures for corrective and preventive actions (CAPA).

Specifically, the firm's CAPA processes lacked effective interim controls to prevent problem recurrence before final corrective actions were implemented. As an example, a CAPA initiated in April 2014 concerned discrepancies between sensor glucose and blood glucose readings from products including the Enlite Sensor MMT-7008, used with Paradigm and Next Generation Pump 630G models. The root cause was identified as "sensor pull out," leading to potential data corruption and loss of sensor function.

Despite this, initial mitigation comments incorrectly stated containment wasn't required. A subsequent CAPA in August 2014 proposed revising product instructions to suggest additional adhesive to address sensor pull-out. However, these proposed corrective actions, including training and instructional changes, had not been implemented since 2014. Critically, no interim controls were established to address the problem while final solutions were pending. Since the CAPAs were opened, the firm received numerous complaints of similar sensor-related events between 2014 and 2017, highlighting the ongoing impact of the unaddressed issues.

The FDA 483 emphasizes the firm's responsibility to conduct internal audits and correct all violations of quality system requirements, underscoring the need for immediate and effective remediation of these CAPA deficiencies to ensure product performance and patient safety.