Dexcom G4 Platinum, G5 Mobile and G6 Sensor Glucose Monitoring System
Published 10 March 2021
Product
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.
Why it was 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.
Hazard
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.
Source: Product Safety Australia. RecallMatch AU provides a screening summary and is independent of the ACCC.