Model note · Insulin Pump
Tandem t:slim X2 insulin pump
The t:slim X2 is a small, touchscreen, rechargeable insulin pump worn by people with diabetes and supported by diabetes clinics, delivering U-100 insulin from a 300 unit cartridge through an infusion set. Paired with a compatible CGM, its Control-IQ algorithm adjusts insulin delivery automatically, and it was the device through which FDA created the alternate controller enabled (ACE) pump category.
The model
Maker, model and type.
- Maker
- Tandem Diabetes Care, Inc.
- Model
- t:slim X2 insulin pump with Control-IQ technology
- Device type
- Insulin Pump
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Size | 7.95 x 5.08 x 1.52 cm | Source |
| Weight with full disposable | 112 g | Source |
| Cartridge volume | 3.0 mL (300 units of U-100 insulin); about 15 units unusable residual | Source |
| Basal and bolus accuracy | Within 5% per IEC 60601-2-24; basal delivered every 5 minutes | Source |
| Occlusion threshold | 30 PSI maximum infusion pressure and occlusion alarm threshold | Source |
| Water protection | IP27, to 0.91 m for up to 30 minutes | Source |
| Operating conditions | 5 to 37 C, 20 to 90% RH non-condensing, -396 to 3,048 m | Source |
| Battery life | Typically 4 to 7 days per charge at 2 units/hr, depending on CGM and app use | Source |
| Minimum alarm volume | 45 dBA at 1 m | Source |
| Charger | 100 to 240 V AC input, 5 V DC USB output, 5 W maximum (Tandem P/N 007866) | Source |
Recalls
Known FDA recalls.
- Z-1258-20222020-09-10
Unexpected fluctuation of remaining battery life display; users told to keep charge above 25%.
FDA record - Z-1811-20222022-05-24
Malfunction 6 (non-volatile memory), inaccurate battery display, touchscreen staying on and unexpected open loop; mitigated by software update.
FDA record - Z-1609-20242024-03-05
t:connect mobile app 2.7 on iOS could crash and relaunch repeatedly, causing excessive Bluetooth traffic and faster pump battery drain.
FDA record - Z-1519-20252025-02-27
Software 7.9 with Control-IQ+ could incorrectly interpolate glucose trends.
FDA record - Z-2343-20252025-07-21
Pumps with revision A and B speakers may show Malfunction 16, losing audible alerts and stopping insulin.
FDA record - Z-0232-20262025-08-05
Software 7.9.0.1 and 7.10.1 with Control-IQ+ paired with a G7 sensor could behave unexpectedly.
FDA record
Safety
Safety warnings from the record.
- Always use the USB cable supplied with the pump to reduce the risk of fire or burns when charging. Source
- Do not operate the pump near flammable anaesthetics or explosive gases. Source
- With gradual altitude changes the cartridge may not vent at once and delivery accuracy can vary by up to 15% until 3 units are delivered. Source
- Software 7.9 with Control-IQ+ could misinterpolate glucose trends, and versions 7.9.0.1 and 7.10.1 paired with a G7 sensor had a further defect; confirm the corrected version is installed. Source
Sources
Where this note comes from.
- Tandem t:slim X2 with Control-IQ 7.8 User Guide (mobile bolus, mg/dL, AW-1011648)
- FDA De Novo DEN180058 decision summary, t:slim X2 with interoperable technology
- openFDA MAUDE problem counts, Tandem t:slim X2
- openFDA recalls, t:slim X2
Not covered: No public document lists what each Malfunction Code number means, so only codes named in FDA recalls (6 and 16) are given, and no public service manual was found.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Insulin Pump