Roche’s Accu-Chek Connect Diabetes Management App has hit yet another snag with the FDA. On February 15, the agency issued a Class 2 Device Recall for certain software versions of the app due to a bug that could lead users to self-administer inappropriate doses of insulin.
Roche issued an update correcting the bug back in June, and has posted notices on the Accu-Chek website urging users to update their app to the newer versions. Still, the agency’s recent notice (spotted by mHealthIntelligence) is the fifth Class 2 Device Recall issued to Roche’s app, all of which cited various bugs and issues with the Bolus Advisor feature leading to incorrect dosage recommendations.
“Due to a software bug, when the OS region of the phone setting is changed, the unit of measure within the app may unexpectedly change,” the agency wrote in the recall notice issued last week. “This creates a risk the app might not transfer the blood glucose result or the user might not correctly input numerical values for carbohydrate used for bolus advice.”
The FDA’s notice cites 67,040 unique users of the most up-to-date Accu-Chek version that is affected by the bug. Although a Class 2 recall does not suggest a reasonable probability of serious adverse events or death, it does indicate a clear risk of temporary or medically reversible adverse consequences for these users.
The recall affects software versions 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0, with the FDA advising users to update to version 2.1.1 and clear all stored data from their accompanying Accu-Chek blood glucose meter before reconnecting with the app. A Roche representative directed MobiHealthNews to a statement released by the last June regarding the bug also recommends those who use the feature to “carefully review and manage” their insulin quantities for the first eight hours after app installation and meter pairing, so that an accurate history can be established for future bolus recommendations.
"Since that update, the app has been stable and has corrected the issue," the spokesperson told MobiHealthNews.
App and software recalls are much less severe for companies than the recall of a more traditional medical device, as they can often be quickly remedied with a patch; however, the Accu-Chek app’s Bolus Advisor feature has clearly established itself as a repeat offender. Roche first received clearance for the app in March of 2015, but less than a month later issued a voluntary recall when internal testing found that changing the phone orientation during a calculation was affecting the bolus calculations of German, Italian, and South African users.
"The bolus recommendation feature of the app was immediately disabled, and Roche Diabetes Care informed healthcare professionals and users of the Accu-Chek Connect diabetes management app in affected countries to be aware of this issue," a Roche spokesperson told MobiHealthNews at the time. "A new version of the application that contained a fix for the screen rotation issue was made available and the bolus advice was enabled again. No impacted versions of Accu-Chek Connect diabetes management app were released in the US.”
Since then, the FDA has issued five Class 2 Recalls to the Accu-Chek app, or to specific versions of the app. All of these were due to various bugs affecting the Bolus Advisor feature.