Devices › Automated insulin dosing , threshold suspend
Device brand name · Automated insulin dosing threshold suspend
t:slim X2 Insulin Pump with Basal-IQ Technology: medical device reports filed with FDA
142,641 reports name it, 2018–2026. Manufacturer given most often on reports: Tandem Diabetes Care. Product code OZO.
- 142,641
- device reports naming the brand
- 0.5% of all MAUDE reports · about 18,223 a year
- 1,916
- reports, 12 months to August 2026
- 1,346 in the 12 months before
- 90.8%
- classified as malfunction
- 79% across the product code
- 0%
- classified as death, as reported
- 26 reports · not verified by FDA
FDA's MAUDE database holds 142,641 reports that name the brand "t:slim X2 Insulin Pump with Basal-IQ Technology" (automated insulin dosing threshold suspend), received between September 2018 and August 2026; the manufacturer given most often on reports is Tandem Diabetes Care. Spellings of one product vary from report to report.
1,916 reports arrived in the 12 months to August 2026, up 42% from 1,346 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (90.8%) and injury (9.2%); across all automated insulin dosing , threshold suspend reports (product code OZO) death is recorded in 0.3% and malfunction in 79%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are pumping stopped (19.9%), device displays incorrect message (12.7%) and incorrect measurement (9.9%). The patient problems coded most often are hyperglycemia, hypoglycemia and elevated ketones/ diabetic ketoacidosis. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 439,495 reports carrying product code OZO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Pumping stopped | 28,417 | 19.9% | 6.5% |
| Device displays incorrect message | 18,062 | 12.7% | 12.9% |
| Incorrect measurementthe device measured wrongly | 14,059 | 9.9% | 3.2% |
| Obstruction of flow | 12,786 | 9% | 7.1% |
| Charging problem | 12,682 | 8.9% | 3% |
| Failure to sense | 9,312 | 6.5% | 2.2% |
| Battery problema problem with the battery | 6,158 | 4.3% | 4.1% |
| Crackthe device cracked | 5,975 | 4.2% | 2.1% |
| Physical resistance/sticking | 5,931 | 4.2% | 1.6% |
| Filling problem | 5,908 | 4.1% | 1.4% |
| False alarm | 4,827 | 3.4% | 1.1% |
| Data problem | 4,078 | 2.9% | 1% |
| Communication or transmission problemthe device could not communicate or transmit | 3,798 | 2.7% | 1.3% |
| Device sensing problem | 3,215 | 2.3% | 0.8% |
| Mechanical problema mechanical problem | 2,620 | 1.8% | 4.1% |
| Poor quality image | 2,400 | 1.7% | 0.6% |
| Leak/splashthe device leaked | 2,210 | 1.5% | 0.6% |
| Date/time-related software problem | 2,128 | 1.5% | 0.7% |
| Partial blockage | 1,574 | 1.1% | 0.4% |
| Inappropriate or unexpected reset | 1,442 | 1% | 0.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperglycemiahigh blood sugar | 7,101 | 5% |
| Hypoglycemialow blood sugar | 5,160 | 3.6% |
| Elevated ketones/ diabetic ketoacidosis | 1,538 | 1.1% |
| No patient involvement | 177 | 0.1% |
| Loss of consciousnesspassing out | 170 | 0.1% |
| Vomitingbeing sick | 162 | 0.1% |
| Nauseafeeling sick | 107 | 0.1% |
| Falla fall | 68 | 0% |
| Seizures | 37 | 0% |
| Convulsion/seizure | 36 | 0% |
| Dehydrationdehydration | 35 | 0% |
| Bruise/contusion | 31 | 0% |
| Bone fracture(s) | 29 | 0% |
| Coma | 27 | 0% |
| Confusion/ disorientation | 27 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | t:slim X2 Insulin Pump with Basal-IQ Technology | Product code OZO | All MAUDE reports |
|---|---|---|---|
| Reports | 142,641 | 439,495 | 26,136,888 |
| Share of that pool | — | 32.5% | 0.5% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 9.2% | 20.6% | 36.2% |
| Classified as malfunction | 90.8% | 79% | 62.3% |
| Filed by the manufacturer | 100% | 100% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code OZO
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| 630G Insulin PUMP MMT-1715K 630G BLACK MG | 86,016 | 583 | 0.4% |
| 530g Insulin Pump | 59,083 | 0 | 0.8% |
| 630G Insulin PUMP MMT-1715KL 630G | 35,095 | 945 | 0.5% |
| Sensor Enlite | 17,978 | 0 | 0% |
| Pump Mmt-1715km 630g 3ml Black Medi | 16,204 | 18 | 0.8% |
| Pump Mmt-1714k 630g Black Mmol Canada | 12,875 | 73 | 0.2% |
| 530g Insulin Pump Mmt-751nas | 12,062 | 32 | 0.6% |
| Sensor Enlite Mmt-7008a | 10,133 | 13 | 0.3% |
| 530G Insulin Pump MMT-751LNAS | 9,062 | 31 | 0.3% |
| 630G Insulin PUMP MMT-1715KR 630G | 5,126 | 161 | 0.8% |
| 530g Insulin Pump Mmt-751nal | 4,753 | 1 | 0.4% |
| 530G Insulin Pump MMT-551NAS | 4,322 | 8 | 0.3% |
| 530g Insulin Pump Mmt-751nab | 3,866 | 6 | 0.4% |
| 530g Insulin Pump Mmt-751nap | 3,596 | 3 | 0.4% |
| T Slim X2 Basal-Iq Mmol/L | 3,121 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about t:slim X2 Insulin Pump with Basal-IQ Technology reports
How many FDA reports name t:slim X2 Insulin Pump with Basal-IQ Technology?
142,641 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,916 in the latest 12 months.
What kinds of events are reported?
malfunction (90.8%) and injury (9.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
pumping stopped (19.9%), device displays incorrect message (12.7%), incorrect measurement (9.9%), obstruction of flow (9%) and charging problem (8.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that t:slim X2 Insulin Pump with Basal-IQ Technology was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.