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FDA product code OZO · class 3 · Unknown
Automated insulin dosing , threshold suspend: medical device reports filed with FDA
439,495 reports carry this product code, 2014–2026; 30 brands with a page.
- 439,495
- reports with this product code
- 1.7% of all MAUDE reports
- 1,907
- reports, 12 months to August 2026
- 4,704 in the 12 months before
- 79%
- classified as malfunction
- 62.3% across all reports
- 0.3%
- classified as death, as reported
- 0.9% across all reports
Product code OZO is FDA's classification for "Automated insulin dosing , threshold suspend" (unknown panel), a class 3 device. 439,495 medical device reports carry this product code, 1.7% of the MAUDE database, from February 2014 to August 2026.
1,907 reports arrived in the 12 months to August 2026, down 59% from 4,704 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 (79%), injury (20.6%) and death (0.3%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Medtronic Puerto Rico Operations | 264,230 | 60.1% |
| Tandem Diabetes Care | 143,707 | 32.7% |
| Medtronic Minimed | 30,353 | 6.9% |
| Dexcom | 253 | 0.1% |
| Medtronic Puerto Rico Operations Juncos | 3 | 0% |
| Ascensia Diabetes Care US | 2 | 0% |
| Becton Dickinson And | 2 | 0% |
| Minimed | 1 | 0% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Device displays incorrect message | 56,536 | 12.9% |
| Breakthe device broke | 41,777 | 9.5% |
| Patient device interaction problem | 33,286 | 7.6% |
| Obstruction of flow | 31,169 | 7.1% |
| Pumping stopped | 28,545 | 6.5% |
| No display/image | 27,302 | 6.2% |
| Power problem | 26,033 | 5.9% |
| Mechanical problema mechanical problem | 18,194 | 4.1% |
| Battery problema problem with the battery | 18,175 | 4.1% |
| Material integrity problema problem with the device material | 16,906 | 3.8% |
| Device difficult to program or calibrate | 15,097 | 3.4% |
| Incorrect measurementthe device measured wrongly | 14,183 | 3.2% |
| Charging problem | 13,111 | 3% |
| Device operates differently than expectedthe device behaved unexpectedly | 10,156 | 2.3% |
| Failure to sense | 9,850 | 2.2% |
| Crackthe device cracked | 9,440 | 2.1% |
| Connection problema connection problem | 9,068 | 2.1% |
| Incorrect, inadequate or imprecise result or readings | 8,650 | 2% |
| Insufficient device problem information | 8,058 | 1.8% |
| Device alarm system | 6,956 | 1.6% |
Questions about automated insulin dosing , threshold suspend reports
What is product code OZO?
FDA's classification code for "Automated insulin dosing , threshold suspend", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
439,495 reports through August 2026, 1,907 of them in the latest 12 months.
Which brands appear most often?
t:slim X2 Insulin Pump with Basal-IQ Technology (139,284), 630G Insulin PUMP MMT-1715K 630G BLACK MG (85,946), 530g Insulin Pump (54,132), 630G Insulin PUMP MMT-1715KL 630G (34,987) and Sensor Enlite (17,779). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.