Dexcom G4 Platinum, G5 Mobile and G6 Sensor Glucose Monitoring System

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.

Reason / Defects: 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. Hazards: 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 to 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.

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.