Devices › Automated insulin dosing device system, single hormonal control
Device brand name · Automated insulin dosing device system single hormonal control
Guardian Link 3 OUS: medical device reports filed with FDA
6,663 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic Minimed. Product code OZP.
- 6,663
- device reports naming the brand
- 0% of all MAUDE reports · about 1,512 a year
- 733
- reports, 12 months to August 2026
- 772 in the 12 months before
- 99.8%
- classified as malfunction
- 85.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 6,663 reports that name the brand "Guardian Link 3 OUS" (automated insulin dosing device system single hormonal control), received between February 2022 and August 2026; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.
733 reports arrived in the 12 months to August 2026, close to the 772 of 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 (99.8%) and injury (0.2%); across all automated insulin dosing device system, single hormonal control reports (product code OZP) death is recorded in 0.1% and malfunction in 85.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are wireless communication problem (89.4%), communication or transmission problem (21.3%) and display or visual feedback problem (8%). The patient problems coded most often are hyperglycemia, hemorrhage/blood loss/bleeding and hypoglycemia. 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 893,215 reports carrying product code OZP. 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 |
|---|---|---|---|
| Wireless communication problema wireless connection problem | 5,954 | 89.4% | 5.2% |
| Communication or transmission problemthe device could not communicate or transmit | 1,418 | 21.3% | 2.3% |
| Display or visual feedback problem | 536 | 8% | 2.2% |
| Battery problema problem with the battery | 443 | 6.6% | 5.2% |
| Calibration problem | 309 | 4.6% | 1.4% |
| Incorrect, inadequate or imprecise result or readings | 153 | 2.3% | 4.1% |
| Failure of device to self-test | 90 | 1.4% | 0.5% |
| Breakthe device broke | 74 | 1.1% | 16.1% |
| Inappropriate or unexpected reset | 18 | 0.3% | 0% |
| Moisture or humidity problem | 18 | 0.3% | 3.9% |
| Manufacturing, packaging or shipping problem | 4 | 0.1% | 0.1% |
| Material integrity problema problem with the device material | 4 | 0.1% | 7.2% |
| Packaging problem | 2 | 0% | 0% |
| Patient device interaction problem | 2 | 0% | 7% |
| Activation problem | 1 | 0% | 0% |
| Computer software problema software problem | 1 | 0% | 2% |
| Device difficult to program or calibrate | 1 | 0% | 2.7% |
| Unauthorized access to computer system | 1 | 0% | 0% |
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 | 103 | 1.5% |
| Hemorrhage/blood loss/bleeding | 46 | 0.7% |
| Hypoglycemialow blood sugar | 27 | 0.4% |
| Discomfortdiscomfort | 10 | 0.2% |
| Confusion/ disorientation | 4 | 0.1% |
| Elevated ketones/ diabetic ketoacidosis | 4 | 0.1% |
| Shaking/tremors | 4 | 0.1% |
| Skin inflammation/ irritation | 4 | 0.1% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 3 | 0% |
| Painpain, site not specified | 3 | 0% |
| Itching sensation | 2 | 0% |
| Malaisegeneral feeling of being unwell | 2 | 0% |
| Bruise/contusion | 1 | 0% |
| Erythemaskin redness | 1 | 0% |
| Fatiguetiredness | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Guardian Link 3 OUS | Product code OZP | All MAUDE reports |
|---|---|---|---|
| Reports | 6,663 | 893,215 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 0.2% | 14.3% | 36.2% |
| Classified as malfunction | 99.8% | 85.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.9% | 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 OZP
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Pump MMT-1780KPK 670G Pathway Black MG | 224,556 | 835 | 0.2% |
| MiniMed 780G US System BLE Connect 3.0 mg/dL | 112,817 | 57,140 | 0.1% |
| MiniMed 770G US System BLE Connect 3.0 mg/dL | 84,685 | 4,838 | 0.2% |
| Pump 1886 780G OUS BLE Pump mg/dL | 84,259 | 36,883 | 0% |
| 670G Insulin Pump MMT-1780KL | 78,230 | 1,121 | 0.2% |
| MiniMed 780G OUS System BLE Connect 3.0 mmol/L | 66,718 | 19,194 | 0% |
| PUMP MMT-1884L MM780G BLE 3.0 mg/ml | 34,846 | 9,703 | 0.1% |
| Pump Mmt-1880l Mm770g Ble Mg | 24,045 | 3,148 | 0.2% |
| Pump Mmt-1782k 670g V4 11 Mm | 23,587 | 137 | 0.1% |
| Pump Mmt-1781k 670g V4 11 Mg | 17,081 | 617 | 0% |
| Xmtr Mmt-7811xww Gst3c Ous | 16,414 | 111 | 0% |
| MiniMed 780G OUS System BLE Connect 3.0 mg/dL | 14,458 | 340 | 0% |
| Xmtr MMT-7811NA GST3C Lockout | 17,012 | 65 | 0% |
| Guardian Link 3 US | 11,310 | 229 | 0% |
| Pump Mmt-1780k 670g 3ml Black | 9,345 | 9 | 0.2% |
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 Guardian Link 3 OUS reports
How many FDA reports name Guardian Link 3 OUS?
6,663 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 733 in the latest 12 months.
What kinds of events are reported?
malfunction (99.8%) and injury (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
wireless communication problem (89.4%), communication or transmission problem (21.3%), display or visual feedback problem (8%), battery problem (6.6%) and calibration problem (4.6%). 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 Guardian Link 3 OUS 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.