OECDReference EN/AU/PS1082964
Tandem t:slim X2 Insulin Pump
Official information organised for easier consultation. The source publication remains authoritative.
Identification
Product identification
- Product
- Tandem t:slim X2 Insulin Pump
- Category
- Medical Devices
- Product domain
- Non-foodNagameAlert treatment
Official information
Risk and measures
- Risk or hazard
- Depletion of the pump battery may lead to interruption of insulin delivery, this could result in the user developing dangerously high blood glucose levels (hyperglycaemia), which can lead to serious health complications.
- Recommendations
- This issue will be rectified via a software update, scheduled for release in August 2020. AMSL Diabetes Customer Care will be individually contacting patients to arrange to complete the update of each insulin pump. Consumers are requested to adhere to the following precautions until this software update is made available: 1. Please take precautions when entering the Transmitter ID into the t:slim X2 insulin pump to ensure that the Transmitter ID is correct before starting a Sensor Session. 2. Periodically check the battery level indicator of the pump; 3. Charge the pump for a short period of time every day (10 to 15 minutes); 4. Avoid frequent full battery discharges; and 5. Ensure that the “Bluetooth Settings” in the “Pump Settings” menu is turned off. For further information, contact AMSL Diabetes Customer Care on 1300 851 056.
Official information
Economic operators
- Manufacturer
- Australasian Medical & Scientific Ltd
Territory
Geography
- Origin
- United States
- Distribution
- Retirada en Australia
- Country of recall
- Australia
Provenance and context
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