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Class 2 Device Recall t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM and t:slim X2 Insulin Pump with BasalIQ Technology |
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| Date Initiated by Firm |
September 10, 2020 |
| Date Posted |
June 10, 2022 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1258-2022 |
| Recall Event ID |
90113 |
| Product Classification |
Sensor, glucose, invasive, non-adjunctive - Product Code PQF
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| Product |
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technology |
| Code Information |
Dexcom G5 - All Serial Numbers; Basal-IQ Technology - Software Versions 6.3.01 and Earlier |
Recalling Firm/
Manufacturer |
Tandem Diabetes Care Inc
11075 Roselle St
San Diego CA 92121-1204
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| For Additional Information Contact |
Susan Morrison
858-866-6880
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Manufacturer Reason
for Recall |
Insulin pumps may display unexpected fluctuation of the remaining battery life so ensure pump battery life does not fall below 25% remaining power. If the battery life drops to less than 5%, insulin delivery will continue for 30 minutes and then the pump will power off and insulin delivery will stop. If the battery reaches 1%, then insulin delivery will stop, which could lead to hyperglycemia.
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FDA Determined
Cause 2 |
Software design |
| Action |
On 09/10/2020, correction notices were sent to customers who were asked to acknowledge Low Power Alerts and Low Power Alarms by tapping "OK" and then charging the pump.
Further, take the following precautions to ensure that your pump is properly charged, and the pump's battery life does not fall below 25% remaining power:
- Periodically check the battery level indicator of your pump
- Charge the pump for a short period of time every day (10 to 15 minutes)
- Avoid full battery discharges
A software update is planned by the end of 2020 that resolves the potential fluctuating battery life display. We will reach out to you to complete the free remote update of your insulin pump when the software update becomes available.
Complete a online form to confirm that you have received this important user communication. Customers with questions were encouraged to contact diabetes@amsl.com.au
In November 2020 software version 6.4.1 was released for all affected insulin pumps except Dexcom G5 Mobile CGM system pumps. On 12/06/2020, Dexcom G5 Mobile CGM system customers were informed that a new software update was available to address the battery issues but that the update requires using the Dexcom G6 CGM system.
On 5/24/22, correction notices were sent to customers in Australia to update to the latest software. t:slim X2 insulin pump with Basal-IQ technology version 6.6 and Control-IQ technology version 7.6 are available with the latest software versions. Software update contact: AMSL: diabetes@amsl.com.au or 1300 851 056. |
| Quantity in Commerce |
5,206 |
| Distribution |
International distribution in the country of Australia. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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