Roche Medical APP was recalled by the FDA for how to fix the bug on the reputation
When the FDA (US Food and Drug Administration) approved the "Xi Da Pu Ben" has not retired, Roche now has to face the paralysis of product recall. In March of this year, Roche's Accu-Chek accessory app received FDA approval, but in just one month, Roche announced that it would recall the app. It is not new for medical APP recalls. As we all know, APP will frequently update versions, add new features, and fix vulnerabilities. And as more and more apps get FDA approval, even the approval of applications, the possibility of recalls is becoming more and more common. APP recalls are not as serious as device recalls because they can often be quickly improved in the form of software patches. But the process is still serious. For example, software vulnerabilities that pose risks to patients in subsequent operations are not only waiting for the upgrade version to be resolved, they will also face the FDA's request for recall, prohibiting downloads until the bug is fixed. Roche's app is currently only available for Android, which helps patients track their blood glucose readings and diabetes symptoms. According to public information, it has the first FDA-approved prescription insulin dose calculator, the “Insulin Consultantâ€. The app provides diabetes patients with a choice report to help them identify trends and patterns in their blood glucose levels and to share their data with caregivers or medical teams via online accounts, emails or text messages. It also receives data from the Bluetooth-enabled Accu-Chek Aviva Connect meter. In the internal test, Roche found that when the APP was used in Germany, South Africa and Italy, if the mobile phone was turned from vertical to horizontal, the calculation would be biased and the insulin recommendations provided would become inaccurate. According to data provided by the FDA, the app has been downloaded about 600 times in the affected countries before the patch is released. “The insulin recommendation function in the app was immediately banned, and the Roche Diabetes Care Department immediately informed the health care professionals in the affected countries and the users of the ACCU-CHEK Connect Diabetes Management App,†Roche said. “The screen was fixed. After the release of the new version of the rotation issue, the insulin recommendation function was enabled again. In the US, we did not release the affected ACCU-CHEK Connect diabetes management app." Roche is also working with the FDA to obtain approval for the Accu-Chek Connect app for the iPhone. In fact, everyone will soon be surprised by the recall of medical apps. In February of this year, AliveCor, a device manufacturer that detected serious heart disease by moving ECG (electrocardiogram), recalled 2.1 according to FDA's three-level recall criteria. .2 version of the AliveECG iOS APP. “AliveCor itself is trying to play down the impact of this incident and is not willing to regard this incident as a “product recall.†Albert Bossky, director of AliveCor affairs management, believes that product recall refers to products placed on the market. Did not achieve the design effect, and then from the market, he went on to explain. "From this definition point of view, we did not list any products, just put it into the App Store, there is a loophole has not been detected This caused the product to crash in use, but we have already withdrawn the app in the first time of the problem and uploaded another one. †A spokesperson for the company said that at first some users complained, but the vast majority of users praised the company for handling problems in a timely manner. Boski added that AliveCor's heart monitor is not a life-sustaining device, so even if a loophole occurs, it won't endanger people's lives. It is understood that the three types of recalls (Class III) in the FDA recall system are usually used for: the function of the products placed on the market does not meet the expectations, but does not involve the field of public health risks, for the implementation of the third type of recall The products only require the company to ensure that the defective products are not sold in the final consumer market. According to MobiHealthNews, in 2014, 31 kinds of digital medical related apps and devices passed the FDA's approval. The successive recalls also sighed the US media. Although the technical situation is not big, it should be given to these companies. Knocking on the alarm: It's about medical health. A bug on an app can be patched. The bug in reputation is always left behind? Brand computer chips, dual-frequency integrated circuits, cross-magnetic induction detection, bringing higher accuracy, reliability and stability. 2. Automatic control system, using special magnetic materials and unique technology, the detection accuracy of the probe is particularly high, and the accurate position of the broken needle is displayed in 8 detection areas. 3. Dual probe design, double detection function, higher safety performance, compared with other types of needle detectors, at the same detection height, the sensitivity is increased by 10%. 4. 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