Devices › Set, administration, intravascular
Device brand name · Uno inset i 60/6 grey tcap 10pk int
Autosoft Xc: medical device reports filed with FDA
20,328 reports name it, 2019–2026. Manufacturer given most often on reports: Unomedical A/S. Product code FPA.
- 20,328
- device reports naming the brand
- 0.1% of all MAUDE reports · about 2,713 a year
- 49
- reports, 12 months to August 2026
- 10,331 in the 12 months before
- 91.7%
- classified as malfunction
- 79.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
20,328 medical device reports received by FDA name the brand "Autosoft Xc" (uno inset i 60/6 grey tcap 10pk int); the manufacturer given most often on reports is Unomedical A/S; received from January 2019 to March 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
49 reports arrived in the 12 months to August 2026, down 100% from 10,331 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 (91.7%) and injury (8.3%); across all set, administration, intravascular reports (product code FPA) death is recorded in 0.2% and malfunction in 79.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material twisted/bent (62%), loss of or failure to bond (12.6%) and leak/splash (7.3%). The patient problems coded most often are hyperglycemia, elevated ketones/ diabetic ketoacidosis 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 349,387 reports carrying product code FPA. 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 |
|---|---|---|---|
| Material twisted/bent | 12,611 | 62% | 12.2% |
| Loss of or failure to bond | 2,565 | 12.6% | 14% |
| Leak/splashthe device leaked | 1,484 | 7.3% | 11.2% |
| Infusion or flow problema problem with flow or infusion | 1,306 | 6.4% | 3% |
| Detachment of device or device componentpart of the device came off | 1,299 | 6.4% | 3.9% |
| Device handling problem | 388 | 1.9% | 1.4% |
| Material deformation | 333 | 1.6% | 0.8% |
| Improper or incorrect procedure or method | 57 | 0.3% | 0.4% |
| Crackthe device cracked | 52 | 0.3% | 1.5% |
| Material perforation | 29 | 0.1% | 0.1% |
| Material integrity problema problem with the device material | 20 | 0.1% | 0.2% |
| Off-label use | 16 | 0.1% | 0% |
| Packaging problem | 15 | 0.1% | 0.1% |
| Complete blockage | 11 | 0.1% | 4.2% |
| Fracturea broken bone | 7 | 0% | 0.1% |
| Breakthe device broke | 5 | 0% | 2.1% |
| Material split, cut or torn | 5 | 0% | 0.2% |
| Mechanical problema mechanical problem | 5 | 0% | 0.1% |
| Premature separation | 3 | 0% | 13.4% |
| Missing test results | 2 | 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 | 9,375 | 46.1% |
| Elevated ketones/ diabetic ketoacidosis | 1,586 | 7.8% |
| Hemorrhage/blood loss/bleeding | 147 | 0.7% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 102 | 0.5% |
| Hypoglycemialow blood sugar | 74 | 0.4% |
| Skin inflammation/ irritation | 51 | 0.3% |
| Painpain, site not specified | 44 | 0.2% |
| Hypersensitivity/allergic reaction | 12 | 0.1% |
| Nauseafeeling sick | 6 | 0% |
| Inflammationinflammation | 5 | 0% |
| Coma | 2 | 0% |
| Intraoperative cardiac valve injury | 2 | 0% |
| Vomitingbeing sick | 2 | 0% |
| Arrhythmia | 1 | 0% |
| Bacterial infectiona bacterial infection | 1 | 0% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Autosoft Xc | Product code FPA | All MAUDE reports |
|---|---|---|---|
| Reports | 20,328 | 349,387 | 26,136,888 |
| Share of that pool | — | 5.8% | 0.1% |
| Classified as death, per 1,000 reports | 0 | 2 | 9 |
| Classified as injury | 8.3% | 20% | 36.2% |
| Classified as malfunction | 91.7% | 79.3% | 62.3% |
| Filed by the manufacturer | 100% | 96.3% | 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 FPA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inset Guard | 47,276 | 47,222 | 0.1% |
| Inset | 26,405 | 25,656 | 0% |
| Quick Set | 23,351 | 23,028 | 0.4% |
| Autosoft 90 | 12,143 | 15 | 0% |
| Access | 14,160 | 0 | 0% |
| Other Accessories | 10,429 | 10,425 | 1.7% |
| Alaris Pump Module Administration Set | 8,492 | 0 | 0.2% |
| Contact Detach | 6,473 | 6,157 | 0.1% |
| Inset 30 | 3,528 | 3,461 | 0% |
| Cadd | 10,811 | 9 | 0.1% |
| Minimed Quick-Set | 3,101 | 6 | 0% |
| Cleo 90 Infusion Set | 3,006 | 23 | 0% |
| Trusteel | 2,886 | 14 | 0% |
| Autosoft 30 | 2,374 | 1 | 0% |
| CADD Cleo Infusion Set | 2,334 | 1,994 | 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 Autosoft Xc reports
How many FDA reports name Autosoft Xc?
20,328 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 49 in the latest 12 months.
What kinds of events are reported?
malfunction (91.7%) and injury (8.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material twisted/bent (62%), loss of or failure to bond (12.6%), leak/splash (7.3%), infusion or flow problem (6.4%) and detachment of device or device component (6.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Autosoft Xc 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.