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

Official notice

10 Mar 2021

Last checked

10 Mar 2021

High riskACCC

An official ACCC notice concerns Dexcom G4 Platinum, G5 Mobile and G6 Sensor Glucose Monitoring System. 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. Published 2021-03-10.

What to do now

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.

Recall number

45ce8f84-4436-4b8d-820c-6f9c42d0d7a4

Official notice

2021-03-10

The 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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Artg Numbers

318476

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Affected products

Product 1

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.

Risk / 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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

AU · Australia

Affected area 1

AU · Australia

Source & status

Source

Tier

beta

Category

HOME

Classification

Pharmacy and medical products

App estimate

high

Recall details

Recall number

45ce8f84-4436-4b8d-820c-6f9c42d0d7a4

Classification

Pharmacy and medical products

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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