| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00224-1 |
| Product Name/Description |
Dexcom G4 PLATINUM and Dexcom G5 Mobile receiver (Continuous Glucose Monitoring Device).
Part Number: MT20649-2, MT22719-2
ARTG Number: 169241 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/03/2016 |
| Responsible Entity |
|
| Reason/Issue |
Dexcom noticed an increase in complaints related to audible alarms and alerts associated with Dexcom G4 PLATINUM and Dexcom G5 Receivers.
As such, all Dexcom customers are being notified that that may not receive an intended audible alarm or alert. As a result, if they rely on hearing the alarm or alert, they may not detect a severe hypoglycaemic (low glucose) or hyperglycaemic (high glucose) event. This includes the fixed low alarm at 3.1 mmol/L, which alerts the user with vibration first, followed by beeps 5 minutes later if not confirmed. The vibration alert should continue to work; however, the audible beeps may not function. The vibration function for the alerts and alarm cannot be disabled by the user. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Emergo is providing customers with instructions on how to test the audible alarms to ensure they are functioning properly. If the alarms and alerts are not functioning, users are advised to contact the local distributor, Australasian Medical and Scientific Ltd (AMSL), for a replacement device. Dexcom is working on implementation of an improved speaker for the receivers. For more information please see https://www.tga.gov.au/alert/dexcom-continuous-glucose-monitor-receivers . This action has been closed-out on 10/05/2017. |
| Contact Information |
02 9006 1662 – Emergo Australia
1300 851 05 – Australasian Medical and Scientific Ltd (AMSL) |