Product description
Dexcom G4 Platinum, G5 Mobile and G6 Sensor Glucose Monitoring System
Product codes: STS-GF-001, STS-GF-004, STS-GS-013, STS-GS-014
ARTG 318476, 330535 and 169241
Dexcom G4 Platinum, G5 Mobile and G6 Sensor are primarily used for monitoring glucose levels for the management of diabetes mellitus.
Product codes: STS-GF-001, STS-GF-004, STS-GS-013, STS-GS-014
ARTG 318476, 330535 and 169241
Dexcom G4 Platinum, G5 Mobile and G6 Sensor are primarily used for monitoring glucose levels for the management of diabetes mellitus.
See a list of details to help identify the product
Reason the product is recalled
The Dexcom Continuous Glucose Monitoring System may show falsely elevated glucose readings for users who are taking hydroxyurea, an anti-neoplastic drug, used primarily in chemotherapy.
Incorrect glucose readings may result in incorrect diabetes treatment decisions.
Incorrect glucose readings may result in incorrect diabetes treatment decisions.
The hazards to consumers
If incorrect information is used to make treatment decisions, this could lead to an incorrect dose of insulin. This may result in failure to treat low blood glucose (hypoglycemia, loss of consciousness, seizure, death) from missed low sensor glucose values and alerts or by causing other errors (for example, hypoglycemia from an insulin dose based on a falsely elevated sensor glucose reading) and may lead to serious health complications.
What consumers should do
AA-Med Pty Ltd will contact affected users in writing.
When using the G4 Platinum, G5 Mobile or G6 Sensor, consumers should read the additional information in the warning sections of the Instructions For Use (IFU) relating to hydroxyurea. The updated warning is as follows:
If you are taking hydroxyurea, your glucose readings may be falsely elevated and result in missed hypoglycemia alerts or errors in diabetes management. The level of inaccuracy depends on the amount of hydroxyurea in your body. Use your meter.
For further information, contact Australasian Medical & Scientific Customer Service by phone
on 1300 851 056.
When using the G4 Platinum, G5 Mobile or G6 Sensor, consumers should read the additional information in the warning sections of the Instructions For Use (IFU) relating to hydroxyurea. The updated warning is as follows:
If you are taking hydroxyurea, your glucose readings may be falsely elevated and result in missed hypoglycemia alerts or errors in diabetes management. The level of inaccuracy depends on the amount of hydroxyurea in your body. Use your meter.
For further information, contact Australasian Medical & Scientific Customer Service by phone
on 1300 851 056.
Details to help identify the product
Supplier running the recall
AA-Med Pty Ltd
Where the product was sold
Nationally
Responsible regulators
Regulators are established or appointed by government. They enforce regulations and rules.
Quote PRA number 2021/18891 when contacting a regulator about this recall.
Recall and remedy questions
Contact the Therapeutic Goods Administration if you have:
- a question about the remedy being offered to you by the business that is responsible for managing this recall, or
- concerns about the way the business is managing this recall.