The QMN Weekly Bulletin
Medical Devices / Inspections and Audits

Abbott Diabetes Care Dinged for Inadequate Complaint Procedures

May 25, 2018
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The FDA cited Abbott Diabetes Care for inadequate complaint evaluation procedures following a November to December 2017 inspection of its Alameda, California, facility.

The one-item Form 483 said the firm’s complaint handling process for the FreeStyle Libre Pro Flash glucose monitoring system didn’t provide adequate instructions for investigating medical device complaints to determine whether the device failed to meet specifications and the relationship of the device to the reported adverse event.

The 483 noted that the firm received a complaint that a patient developed an infection while using the FreeStyle Libre Pro glucose monitoring system, and the firm submitted an MDR for the adverse event, but the firm’s investigation didn’t include a review of the device history record or a testing of retained product.

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