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Tandem t:slim X2 Insulin Pump

Published: May 27, 2020Recall ID: 179266af-5942-4517-bf9b-e0a5b24a1b9cCategory: Consumer ProductsCountry: Australia
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Reason for Recall / Hazard

The pump battery may deplete faster than expected in certain circumstances. Only patients using the pump displaying Dexcom G5 Continuous Glucose Monitor (CGM) values are affected by this issue. If a Transmitter ID is entered incorrectly into the pump, the pump will be unable to connect to the transmitter and will continue to search for that transmitter until the battery charge is depleted or a correct Transmitter ID is entered.

Product Description & Identification

Reason / Defects: The pump battery may deplete faster than expected in certain circumstances. Only patients using the pump displaying Dexcom G5 Continuous Glucose Monitor (CGM) values are affected by this issue. If a Transmitter ID is entered incorrectly into the pump, the pump will be unable to connect to the transmitter and will continue to search for that transmitter until the battery charge is depleted or a correct Transmitter ID is entered. Hazards: 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. What to do: 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.

Affected Products

Tandem Diabetes Care t:slim X2 Insulin Pump The Tandem Diabetes Care t:slim X2 Insulin Pump is intended for continuous insulin delivery and delivery of user activated insulin boluses, for the management of diabetes mellitus in persons requiring insulin. ARTG 304681 (Australasian Medical & Scientific Ltd - Infusion pump, insulin, ambulatory)

Additional Source Details

FieldValue
Guid › #text179266af-5942-4517-bf9b-e0a5b24a1b9c
Guid › @ is Perma Linkfalse
Linkhttps://www.productsafety.gov.au/search-consumer-product-recalls/tandem-tslim-x2-insulin-pump
Pub DateWed, 27 May 2020 00:00:00 +0000
Extracted imagehttps://www.productsafety.gov.au/system/files/styles/large/private/Tslim%20X2%20Insulin%20Pump.jpg?itok=F5EIaK5p

Consumer Action Protocol: What You Should Do Immediately

Safety Steps
1Verify Product Identifiers

Check the model number, serial number, and date stamp on the rating label on the back or underside of the product.

2Isolate & Discontinue Use

Immediately discontinue using the product. Unplug electrical items and keep juvenile items out of reach of children.

3Claim Free Statutory Remedy

Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.

4Report Adverse Incidents

If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (Australia Products).

Your Legal Rights as a Consumer

Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.

Frequently Asked Questions About This Recall

FAQ Guide

Q1:What should I do immediately if I own or bought Tandem t:slim X2 Insulin Pump?

Immediately stop using the product and keep it out of reach of children. Disconnect power if electrical, and do not attempt makeshift home repairs.

Q2:Can I get a full refund or free repair for this recall?

Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.

Q3:Do I need my original sales receipt to claim a remedy or refund?

In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.

Q4:Where can I verify official information for this safety alert?

This safety alert is aggregated directly from official regulatory agency records (Australia Products). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.

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Overview

  • Risk LevelPharmacy and medical products
  • DistributionAustralia
Recall Hazard Severity
Caution (Class III)
Official Agency Alert

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