Autosoft XC 1001680Recalls & reported problems
Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2
Quick summary
This Autosoft XC infusion set has 13,437 adverse event reports, including 2,617 injuries and no deaths. Many describe bent or twisted tubing, parts that loosen or separate, and leaks, and many patient reports mention high blood sugar or diabetic ketoacidosis. Reports rose from 2,878 in the prior 12 months to 5,071 in the latest 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 16,105
- Deaths reported
- 1
- Injuries reported
- 3,570
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16,105 adverse event reports that list this exact device (DI 05705244016620), received between Dec 13, 2018 and Sep 30, 2026 — classified as 1 death, 3,570 injuries, 12,534 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (6,546 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent6,546
- Loss of or Failure to Bond2,999
- Premature Separation2,134
- Leak/Splash1,515
- Complete Blockage1,020
- Detachment of Device or Device Component994
- Infusion or Flow Problem792
- Use of Incorrect Control/Treatment Settings618
Patient problems
- No Clinical Signs, Symptoms or Conditions8,049
- Hyperglycemia6,731
- Elevated Ketones/ Diabetic Ketoacidosis1,059
- Hemorrhage/Blood Loss/Bleeding107
- Skin Inflammation/ Irritation63
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available53
- Hypoglycemia49
- Pain39
Recent adverse event reports
The 25 most recent of 16,105 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced hyperglycemia caused by three separate bent cannula events at their abdomen insertion site, with each individual infusion set failing in less than 24 hours. Two of these events occurred within the span of a single month, during which the patient noticed symptoms within 3 hours of insertion for one set, and 3 or more hours after insertion for the other. The final bent cannula incident took place on 28-Aug-2026. All resulting high blood glucose (BG) episodes were managed and treated using correction injections via multiple daily injections (MDI).
Patient problems: Hyperglycemia
MAUDE report 50951256 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 50951083 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient experienced an event on (b)(6) 2026 in which infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950115 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950112 ↗InjurySep 30, 2026Complete Blockage
It was reported that the patient experienced recurrent occlusion alarms due to a blockage in the infusion set tubing on (b)(6)2026, resulting in hyperglycemia and was treated with correction insulin injection.
Patient problems: Hyperglycemia
MAUDE report 50949088 ↗InjurySep 30, 2026Complete Blockage
It was reported that the patient experienced recurring occlusion alarms associated with the infusion set identifying a blockage in the tubing, resulting high blood glucose and was treated with correction bolus via the pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948984 ↗InjurySep 30, 2026Complete Blockage
It was reported that the patient experienced occlusion alarms due to a blockage in the infusion set tubing, resulting in hyperglycemia and was treated with a correction insulin injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948981 ↗MalfunctionSep 30, 2026Complete Blockage
It was reported that the patient experienced an occlusion alarm (Alarm 2) caused by a blockage in the infusion set tubing on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948971 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50948614 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced bent cannula event resulting in High Blood Glucose level treated with Changed site, took a bolus on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948607 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced an occlusion alarm associated with a kinked cannula after more than 3 hours of use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948583 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient experienced occlusion alarms associated with a kinked Cannula on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948576 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the Patient had experienced infusion set cannula was bent which led to occlusion at site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948331 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was used for three hours resulted in kinked cannula led to occlusion at site on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947960 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that the patient faced an event where the infusion set which was in use for three hours resulted in kinked cannula led to occlusion and experienced Hyperglycemia resolved by infusion set change on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50947956 ↗MalfunctionSep 30, 2026Break
It was reported that the patient experienced Infusion set spring detached from outer ring of inserter prior to insertion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946885 ↗MalfunctionSep 30, 2026Break
It was reported that the patient experienced Infusion set spring detached from outer ring of inserter prior to insertion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946877 ↗MalfunctionSep 30, 2026Break
It was reported that the patient experienced Infusion set spring detached from outer ring of inserter prior to insertion event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946876 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50946384 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced a kinked infusion set cannula and high blood glucose reported. The event was treated with a correction insulin injection via Multiple Daily Injections on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946382 ↗InjurySep 30, 2026Material Twisted/Bent
It was reported that the patient experienced a kinked infusion set cannula and high blood glucose reported .The event was treated with a correction bolus via the insulin pump on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50946085 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50945932 ↗InjurySep 30, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50945926 ↗MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient experienced an event on 28-Aug-2026 where infusion set cannula was kinked which leads to occlusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945777 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing leakage issue at the site on (b)(6) 2026. The issue occurred with four infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945561 ↗
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
- Autosoft XC 1006922Unomedical A/S · Set, Administration, Intravascular3,990 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.