Autosoft30™ 1002826Recalls & 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 Autosoft30 is a single-use infusion set that delivers medicine under the skin. Its 408 adverse event reports often describe parts separating or failing to bond, leaks, and twisted or bent tubing, and some describe high blood sugar and ketoacidosis. The reports include no deaths and 63 injuries. No recalls name this device. Reports rose from 74 in the earlier year to 184 in the latest year.
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
- 452
- Deaths reported
- 0
- Injuries reported
- 78
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 452 adverse event reports that list this exact device (DI 05705244018396), received between Jan 19, 2021 and Sep 30, 2026 — classified as 78 injuries, 374 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (124 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
- Loss of or Failure to Bond124
- Premature Separation97
- Material Twisted/Bent86
- Leak/Splash51
- Fluid/Blood Leak33
- Detachment of Device or Device Component32
- Device Handling Problem30
- Infusion or Flow Problem26
Patient problems
- No Clinical Signs, Symptoms or Conditions287
- Hyperglycemia142
- Elevated Ketones/ Diabetic Ketoacidosis32
- Unspecified Infection11
- Hemorrhage/Blood Loss/Bleeding3
- Hypoglycemia2
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 25 most recent of 452 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that the patient faced an event where adhesive patch and cannula housing detached from spring prior to insertion on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944088 ↗MalfunctionSep 30, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient faced accidental pull-out of the infusion set during use due to the tubing catching on something or the pump falling on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943732 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908164 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908163 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908162 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908161 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908138 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882794 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing was leaking at the site event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881770 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing was leaking at the site event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881768 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing was leaking at the site event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881756 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881751 ↗MalfunctionSep 24, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881747 ↗InjurySep 23, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50867662 ↗InjurySep 23, 2026Device Handling Problem
It was reported the six events where patient has inserted into scar tissue, muscle or over bone, which is considered as misuse, this resulted in elevated blood glucose levels that was managed with self-administered insulin via Multi Daily Injection therapy.
Patient problems: Hyperglycemia
MAUDE report 50867656 ↗InjurySep 23, 2026Device Handling Problem
It was reported the six events where patient has inserted into scar tissue, muscle or over bone, which is considered as misuse, this resulted in elevated blood glucose levels that was managed with self-administered insulin via Multi Daily Injection therapy.
Patient problems: Hyperglycemia
MAUDE report 50867654 ↗InjurySep 23, 2026Device Handling Problem
It was reported the six events where patient has inserted into scar tissue, muscle or over bone, which is considered as misuse, this resulted in elevated blood glucose levels that was managed with self-administered insulin via Multi Daily Injection therapy.
Patient problems: Hyperglycemia
MAUDE report 50867653 ↗InjurySep 23, 2026Device Handling Problem
It was reported the six events where patient has inserted into scar tissue, muscle or over bone, which is considered as misuse, this resulted in elevated blood glucose levels that was managed with self-administered insulin via Multi Daily Injection therapy.
Patient problems: Hyperglycemia
MAUDE report 50867649 ↗InjurySep 23, 2026Device Handling Problem
It was reported the six events where patient has inserted into scar tissue, muscle or over bone, which is considered as misuse, this resulted in elevated blood glucose levels that was managed with self-administered insulin via Multi Daily Injection therapy.
Patient problems: Hyperglycemia
MAUDE report 50867489 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event of infusion set patch did not stick to skin upon insertion on (b)(6)2026. Insertion site was abdomen. Patient faced same issue in two infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864130 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient faced an event of infusion set patch did not stick to skin upon insertion on (b)(6)2026. Insertion site was abdomen. Patient faced same issue in two infusion sets.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864117 ↗InjurySep 20, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50834658 ↗InjurySep 20, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50834657 ↗MalfunctionSep 18, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822320 ↗MalfunctionSep 18, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50822275 ↗
Other Set, Administration, Intravascular devices
- Autosoft XC 1001680Unomedical A/S · Set, Administration, Intravascular1 death16,105 reports
- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.