Dexcom one, Dexcom G7, Dexcom One Plus receivers Priority 2 - Warning
10/07/2026
Medical devices
HPRA safety notice
| Point of information | Details |
| Device manufacturer/supplier Information | Dexcom Inc. |
| Target audience | Patients / Users of these devices / Healthcare professionals and healthcare settings involved in the use and/or provision of these devices. |
| What devices are affected? | Dexcom G7 Receiver |
Problem or issue?
Dexcom has become aware that certain users of Dexcom G7 receivers may experience an issue where alarms/alerts do not function as designed. This is due to a speaker malfunction. As a result, the alarm/alert may not provide audio output when an audio prompt would normally be expected. An impacted receiver will still provide an alert through vibration and visual prompts.
What is the risk?
If the issue occurs, it could result in missed detection or treatment of severe hypoglycaemia or hyperglycaemia.
Why is the HPRA issuing this safety notice?
Dexcom issued a field safety notice (FSN) in May 2025 regarding this issue. The manufacturer recommends that users of the device verify whether their receiver is affected and, if so, contact Dexcom Technical Support to obtain a replacement. Since the circulation of the manufacturers FSN, the HPRA has been engaging with Dexcom to ensure appropriate awareness of this issue. However, to date, the number of replacement receivers requested by users in Ireland has been low. As such, the HPRA is issuing this safety notice at this time, to further raise awareness of this issue and to ensure impacted users undertake the actions outlined in the manufacturers FSN.
What advice has the HPRA for users of these devices?
- Refer to the accompanying FSN and follow the instructions provided by the manufacturer.
- Check the serial number for any receiver(s) you use (with a part number listed in manufacturer’s FSN) by visiting https://www.dexcom.com/checkreceiver to verify if your receiver is affected by this issue.
- If your receiver is affected, contact Dexcom Technical Support to obtain a replacement.
- Irrespective of whether your receiver is affected, test the speaker function every time you charge your receiver. The malfunction can occur anytime without warning, even if the receiver was initially not affected by this issue
- Users can electively test the receiver speaker at any point through the menu: Menu>Information>Receiver>Speaker>Test
- Report any safety issues associated with these devices to the manufacturer and to the HPRA.
Contact Information
| Manufacturer | Authorised Representative | |
| Name: | Dexcom Inc. | MDSS GmbH |
| Address: | 6340 Sequence Drive, San Diego, USA, 92121 | Schiffgraben 41, Hannover, Germany, 30175 |
| Email: | ukie.sales@dexcom.com | vigilance@mdssar.com |
| Telephone: | +1-858-529-4548 | +49 511 6262 8630 |
| Website: | https://www.dexcom.com/en-IE | www.mdss.com |
HPRA contact Information
All safety issues relating to medical devices should be reported to the HPRA using any of the following reporting options:
- HPRA online report form
- Telephone: +353-1-6764971
Further information on the role of the HPRA in relation to medical devices is available on the regulation of medical devices section of the HPRA website.
Any enquiries regarding this safety notice or any medical device safety issue should be emailed to us using our online contact form.
Documents
Opens in new window Dexcom One, G7 and One plus receivers - Field safety notice for users - July 2026 - speaker malfunction PDF : 225KB | 09/07/2026Product images
