Autosoft XC 1001681Recalls & 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 Unomedical Autosoft XC infusion set is a single-use tube that delivers medicine under the skin. Many reports describe bent or twisted material, bonds that fail, and leaks. The 3,719 reports include 1 death and 545 injuries, and 1,495 mention high blood sugar. 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
- 4,216
- Deaths reported
- 1
- Injuries reported
- 750
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4,216 adverse event reports that list this exact device (DI 05705244016651), received between Jan 8, 2019 and Sep 30, 2026 — classified as 1 death, 750 injuries, 3,465 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (1,483 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/Bent1,483
- Loss of or Failure to Bond763
- Leak/Splash481
- Detachment of Device or Device Component394
- Premature Separation393
- Infusion or Flow Problem303
- Complete Blockage164
- Fluid/Blood Leak152
Patient problems
- No Clinical Signs, Symptoms or Conditions2,213
- Hyperglycemia1,706
- Elevated Ketones/ Diabetic Ketoacidosis265
- Hemorrhage/Blood Loss/Bleeding29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Hypoglycemia6
- Pain5
- Skin Infection5
Recent adverse event reports
The 25 most recent of 4,216 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Partial Blockage; Material Twisted/Bent
It was reported that a kinked infusion set cannula caused occlusion alarms due to a blockage at the infusion site, resulting in elevated blood glucose levels on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50948718 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where three infusion set patches was not sticking to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945333 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where three infusion set patches was not sticking to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945328 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event where three infusion set patches was not sticking to skin upon insertion on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945300 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944550 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944548 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944546 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6)2026 where the infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944544 ↗MalfunctionSep 30, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an issue with infusion set on (b)(6) 2026 where the infusion set fell off during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944529 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient four infusion set had high blood glucose (400-500 mg/dl) and treated with Correction injection via Multiple daily injection and had positive diabetic keto acidosis levels on (b)(6) 2026.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50944154 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient four infusion set had high blood glucose (400-500 mg/dl) and treated with Correction injection via Multiple daily injection and had positive diabetic keto acidosis levels on (b)(6) 2026.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50944146 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient four infusion set had high blood glucose (400-500 mg/dl) and treated with Correction injection via Multiple daily injection and had positive diabetic keto acidosis levels on (b)(6) 2026.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50944145 ↗InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Patient four infusion set had high blood glucose (400-500 mg/dl) and treated with Correction injection via Multiple daily injection and had positive diabetic keto acidosis levels on (b)(6) 2026.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia
MAUDE report 50944087 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site with ten infusion sets (had been in use for approximately 24 to 36 hours) the same issue type beginning on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941887 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site after approximately three hours of use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941865 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site with ten infusion sets (had been in use for approximately 24 to 36 hours) the same issue type beginning on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941859 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site after approximately one day of use on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941857 ↗MalfunctionSep 30, 2026Partial Blockage
It was reported that the patient experienced recurring occlusion alarms (Alarm 2) associated with the infusion set site from (b)(6) .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941781 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937024 ↗InjurySep 29, 2026Partial Blockage; Material Twisted/Bent
It was reported that patient experienced an issue on (b)(6) 2026 where infusion set cannula was kinked which leads to occlusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936668 ↗MalfunctionSep 29, 2026Partial Blockage; Material Twisted/Bent
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936366 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set fell off event on (b)(6) 2026 during use.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936354 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936345 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936012 ↗InjurySep 29, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced infusion set cannula was kinked causing high blood glucose level 412 mg/dl and was treated with insulin pump event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50932193 ↗
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- 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.