Devices › Automated insulin dosing , threshold suspend
Device brand name · Ozo
Sensor Enlite: medical device reports filed with FDA
17,978 reports name it, 2013–2022. Manufacturer given most often on reports: Medtronic Minimed. Product code OZO.
- 17,978
- device reports naming the brand
- 0.1% of all MAUDE reports · about 1,411 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 84.3%
- classified as malfunction
- 79% across the product code
- 0%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 17,978 reports that name the brand "Sensor Enlite" (ozo), received between October 2013 and December 2022; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 (84.3%) and injury (15.6%); 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 device displays incorrect message (26.1%), incorrect, inadequate or imprecise result or readings (15.6%) and incorrect or inadequate test results (13.4%). The patient problems coded most often are hyperglycemia, hypoglycemia and hemorrhage/blood loss/bleeding. 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 |
|---|---|---|---|
| Device displays incorrect message | 4,684 | 26.1% | 12.9% |
| Incorrect, inadequate or imprecise result or readings | 2,809 | 15.6% | 2% |
| Incorrect or inadequate test results | 2,417 | 13.4% | 1% |
| Device operates differently than expectedthe device behaved unexpectedly | 2,146 | 11.9% | 2.3% |
| Component missing | 2,084 | 11.6% | 0.9% |
| Bent | 1,615 | 9% | 1.2% |
| Breakthe device broke | 1,545 | 8.6% | 9.5% |
| False reading from device non-compliance | 927 | 5.2% | 0.4% |
| Calibration error | 845 | 4.7% | 0.3% |
| Detachment of device component | 548 | 3% | 0.4% |
| Low readingsreadings were too low | 540 | 3% | 0.2% |
| Device inoperablethe device could not be used | 500 | 2.8% | 1.2% |
| Loss of threshold | 387 | 2.2% | 0.1% |
| Sticking | 379 | 2.1% | 0.3% |
| Communication or transmission problemthe device could not communicate or transmit | 374 | 2.1% | 1.3% |
| Calibration problem | 284 | 1.6% | 0.3% |
| Insufficient device problem information | 232 | 1.3% | 1.8% |
| Improper or incorrect procedure or method | 210 | 1.2% | 0.4% |
| Device alarm system | 208 | 1.2% | 1.6% |
| Low test results | 186 | 1% | 0.1% |
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 | 8,014 | 44.6% |
| Hypoglycemialow blood sugar | 2,651 | 14.7% |
| Hemorrhage/blood loss/bleeding | 258 | 1.4% |
| Elevated ketones/ diabetic ketoacidosis | 102 | 0.6% |
| Painpain, site not specified | 101 | 0.6% |
| Skin irritationirritated skin | 90 | 0.5% |
| Device embedded in tissue or plaque | 66 | 0.4% |
| Loss of consciousnesspassing out | 65 | 0.4% |
| Foreign body in patientpart of a device left in the patient | 52 | 0.3% |
| Erythemaskin redness | 49 | 0.3% |
| Complaint, ill-defined | 43 | 0.2% |
| Swellingswelling | 43 | 0.2% |
| Seizures | 39 | 0.2% |
| Itching sensation | 37 | 0.2% |
| Blood loss | 36 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sensor Enlite | Product code OZO | All MAUDE reports |
|---|---|---|---|
| Reports | 17,978 | 439,495 | 26,136,888 |
| Share of that pool | — | 4.1% | 0.1% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 15.6% | 20.6% | 36.2% |
| Classified as malfunction | 84.3% | 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 |
|---|---|---|---|
| t:slim X2 Insulin Pump with Basal-IQ Technology | 142,641 | 1,916 | 0% |
| 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% |
| 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 Sensor Enlite reports
How many FDA reports name Sensor Enlite?
17,978 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (84.3%) and injury (15.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device displays incorrect message (26.1%), incorrect, inadequate or imprecise result or readings (15.6%), incorrect or inadequate test results (13.4%), device operates differently than expected (11.9%) and component missing (11.6%). 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 Sensor Enlite 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.