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Device brand name · Medical device data system
Sftwr Mmt-6122 Fota Ios Ous/Us: medical device reports filed with FDA
632 reports name it, 2023–2025. Manufacturer given most often on reports: Medtronic Minimed. Product code OUG.
- 632
- device reports naming the brand
- 0% of all MAUDE reports · about 200 a year
- 0
- reports, 12 months to August 2026
- 7 in the 12 months before
- 99.8%
- classified as malfunction
- 95.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
632 medical device reports received by FDA name the brand "Sftwr Mmt-6122 Fota Ios Ous/Us" (medical device data system); the manufacturer given most often on reports is Medtronic Minimed; received from May 2023 to April 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, against 7 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 (99.8%) and injury (0.2%); across all medical device data system reports (product code OUG) death is recorded in 0.3% and malfunction in 95.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are computer software problem (75.3%), wireless communication problem (32.3%) and problem with software installation (4%). The patient problems coded most often are 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 2,983 reports carrying product code OUG. 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 |
|---|---|---|---|
| Computer software problema software problem | 476 | 75.3% | 50.3% |
| Wireless communication problema wireless connection problem | 204 | 32.3% | 42.1% |
| Problem with software installation | 25 | 4% | 1.7% |
| Application network problem | 2 | 0.3% | 0.2% |
| Calibration problem | 1 | 0.2% | 0.1% |
| Device alarm system | 1 | 0.2% | 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 |
|---|---|---|
| Hypoglycemialow blood sugar | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sftwr Mmt-6122 Fota Ios Ous/Us | Product code OUG | All MAUDE reports |
|---|---|---|---|
| Reports | 632 | 2,983 | 26,136,888 |
| Share of that pool | — | 21.2% | 0% |
| Classified as death, per 1,000 reports | 0 | 3 | 9 |
| Classified as injury | 0.2% | 1.6% | 36.2% |
| Classified as malfunction | 99.8% | 95.5% | 62.3% |
| Filed by the manufacturer | 100% | 95% | 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 OUG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Unknown Fota Sftwr | 784 | 194 | 0% |
| Sftwr Mmt-6121 Fota Android Ous/Us | 648 | 0 | 0% |
| Pentax | 47,288 | 2,443 | 0.1% |
| Pkg Connected Or Hub Base System | 158 | 61 | 0.6% |
| Epic | 429 | 32 | 1.2% |
| Carelink System | 343 | 0 | 0.3% |
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 Sftwr Mmt-6122 Fota Ios Ous/Us reports
How many FDA reports name Sftwr Mmt-6122 Fota Ios Ous/Us?
632 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 (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?
computer software problem (75.3%), wireless communication problem (32.3%), problem with software installation (4%), application network problem (0.3%) and calibration problem (0.2%). 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 Sftwr Mmt-6122 Fota Ios Ous/Us 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.