| Date Initiated by Firm |
June 08, 2017 |
| Create Date |
February 15, 2018 |
| Recall Status1 |
Terminated 3 on July 27, 2018 |
| Recall Number |
Z-0625-2018 |
| Recall Event ID |
79001 |
| 510(K)Number |
K150910
|
| Product Classification |
Calculator, drug dose - Product Code NDC
|
| Product |
Accu-Chek Connect Diabetes Management App, Catalog number 07562462001 / GTIN number 00365702700000 & Catalog number 07250452001 / GTIN number 00365702700017 |
| Code Information |
Software Versions: 1.2.0, 1.2.2, 1.2.3, 2.0.0, 2.0.1, and 2.1.0 |
Recalling Firm/
Manufacturer |
Roche Diabetes Care, Inc.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
Anne Gill
317-521-4312
|
Manufacturer Reason
for Recall |
Certain iOS and Android App versions contain a program error (bug) in the Bolus Advisor feature. 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. 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.
|
FDA Determined
Cause 2 |
Other |
| Action |
On 06/13/2017, Roche Diabetes Care, Inc. made the Urgent Medical Device Correction notice available to their customers through the Accu-Chek.com website and through the Accu-Chek Connect microsite. Patients are instructed to:
Update to version 2.1.1 of the Accu-Chek Connect app
Clear all data from the Accu-Chek blood glucose meter following the steps below, before pairing with the Accu-Chek Connect app for the first time. This clearing of the records in the memory can be accomplished on the PC or Mac by using Accu-Chek Connect Device Link. A micro-USB cable and an Accu-Chek Connect Online account are required. Also ensure that the date and time are set correctly on the blood glucose meter before pairing with the app. Failure to follow these directions might impact first time use of the apps Bolus Advisor feature.
¿ Steps to clear data from Accu-Chek meter in Connect Online:
1. Create or login to your Connect Online account on your PC or Mac.
2. Download Accu-Chek Device Link
3. Right-click on Device Link icon in system tray or dock.
4. Select Settings > Prompt after every successful upload under the Delete Patient Results from Device heading.
5. Connect your meter via micro-USB cable.
6. Follow the onscreen instructions to upload your data and clear your meter.
If you use the apps Bolus Advisor feature, please carefully review and manage your active insulin and insulin bolus amounts for the first 8 hours after initial installation of the app and pairing your meter. This ensures the software will establish an accurate history for use in future bolus recommendations.
They are advised to contact Accu-Chek Customer Care at 1-800-688-4578 if there are additional questions. |
| Quantity in Commerce |
67,040 unique users of version 2.1.0 |
| Distribution |
US Nationwide |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = NDC and Original Applicant = ROCHE DIABETES CARE INC.
|
