| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01168-1 |
| Product Name/Description |
Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5)
(used in conjunction with Roche Accu-Chek Avica Connect and Accu-Chek Guide Blood Glucose Meters).
ARTG Number: 224385
An in vitro diagnostic medical device (IVD) |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
7/09/2016 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diabetes Care has identified a programming error in the Accu-Chek Connect diabetes management app iOS version 1.2.0(.5) which under certain conditions could potentially lead to an inaccurate bolus insulin advice being provided to the patients. As a result of this issue the app “lightbulb” icon is not displayed and the correction bolus advice is not available.. The blood glucose (bG) value which could not be used initially may unintentionally become available for bolus advice calculation at a later time. If the patients then request a bolus advice for a bG value older than 10 minutes without taking and transferring a new bG measurement, it could lead to an incorrect bolus insulin recommendation. Depending on the actual metabolic situation a potentially incorrect bolus advice could lead to serious health consequences. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Roche is advising Health Care Professionals to inform their patients by distributing a copy of the letter, to whom the Accu-Chek Connect diabetes management app has been distributed. Patients are being advised to discontinue using version 1.2.0.5 and update their app immediately to version 1.2.2.2. This action has been closed-out on 12/05/2017. |
| Contact Information |
1800 251 816 - Roche Diabetes Care Contact Centre |