Krouwer Consulting, Sherborn, MA, USA.
J Diabetes Sci Technol. 2022 Sep;16(5):1299-1302. doi: 10.1177/19322968211011688. Epub 2021 May 8.
Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report summarizes the number of adverse events for the years 2018 to 2020 for the 3 diabetes devices: blood glucose meters (BG), continuous glucose monitors (CGM), and insulin pumps. A text example of a CGM injury is provided. Possible reasons are suggested for trends. Whereas the rate per test result (events/usage) is exceedingly small, the rate per patient (events/people with diabetes that use insulin) is of concern. Hence, it is important to determine event causes and provide corrective actions. The first step is to put in place routine analysis of adverse event data for diabetes devices.
与通常在理想条件下进行的绩效评估不同，在糖尿病患者实际使用设备时会发生不良事件。本报告总结了 2018 年至 2020 年 3 种糖尿病设备（血糖仪 (BG)、连续血糖监测仪 (CGM) 和胰岛素泵）的不良事件数量。提供了 CGM 损伤的文本示例。针对趋势提出了可能的原因。虽然每次测试结果（事件/使用）的发生率极低，但每例患者（使用胰岛素的糖尿病患者）的发生率令人担忧。因此，确定事件原因并采取纠正措施非常重要。第一步是对糖尿病设备的不良事件数据进行常规分析。
