| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00592-1 |
| Product Name/Description |
Accu-Chek Mobile Blood Glucose Meter
ARTG Number: 190251 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
28/05/2014 |
| Responsible Entity |
|
| Reason/Issue |
Roche Diagnostics has identified that a small number of people with diabetes using the Accu-Chek Mobile device have experienced falsely elevated blood glucose readings when using the system as a result of not following the described and labelled handling instructions. Such improper handling can include, for example, unclean hands contaminated with glucose-containing substances, pressing the finger too hard and too long on the test field or smearing the blood while performing a test. Roche has decided to enhance its training and handling instructions for the Accu-Chek Mobile system – increasing their visibility in the meter kit to ensure people with diabetes’ understanding of how to appropriately use the system. This will enable the users to obtain safe and reliable blood glucose (bG) readings at all times.br /br /The TGA has published a web statement regarding this issue. For more information, pleaser refer to: http://www.tga.gov.au/safety/alerts-device-accu-chek-glucose-meter-140606.htm |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Consumers are advised to continue to use their Accu-Chek Mobile device safely and reliably by carefully following the instructions that are described in the User Manual and which can also be found in a new instructions leaflet available at www.accu-chek.com.au. Specifically:
· Wash your hands with warm water and soap. Dry your hands thoroughly before obtaining a blood sample.
· Form a proper blood drop and apply it to the centre of the test field.
· Immediately apply the blood gently to the test field after you have created the blood drop.
· Do not press against the test field on the tape.
· Touch the test area gently and your finger should be removed from the test field when the beep tone sounds and/or “test in progress” is displayed. |
| Contact Information |
1800 800 535 - Accu-Chek Contact Centre |