FDA 483 - Cerner Corp - June 21, 2017

An FDA inspection of Cerner Corporation, a medical device manufacturer and complaint handling unit, was conducted from June 13 to June 21, 2017. The inspection revealed critical non-compliance with regulatory requirements, leading to three significant observations. Firstly, Cerner failed to submit Medical Device Reports (MDRs) within 30 days for numerous malfunctions in its Blood Bank medical device software. These malfunctions included instances where the system allowed incorrect blood crossmatches, processed unscreened blood units, and displayed erroneous ABO/Rh blood types, all of which presented a likelihood of causing serious injury or death. Secondly, the company did not provide written notification to the FDA regarding a significant software correction implemented to reduce a health risk. This correction addressed a potential issue where the system could approve an incorrect Rh factor due to auto-verification. Finally, Cerner's complaint handling procedures were not uniformly or timely implemented. Numerous service records detailing urgent patient safety concerns, such as missing historical blood bank records and major system outages affecting patient care, were not appropriately flagged for evaluation according to the company's own guidelines. Cerner Corporation is required to provide a formal response to the FDA outlining detailed corrective actions for each identified deficiency to ensure full regulatory compliance.