Autosoft90™ 1000282Recalls & 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 Autosoft90 infusion set has 349 adverse event reports on file, with no deaths and 27 injuries. Reports describe parts twisting or bending, coming apart, and leaking, and many mention high blood sugar, with some describing diabetic ketoacidosis. No recalls name this device. Reports in the last 12 months fell to 25 from 90 in the prior 12 months.
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
- 359
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 05705244014572), received between Feb 1, 2019 and Sep 28, 2026 — classified as 35 injuries, 324 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (137 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/Bent137
- Detachment of Device or Device Component78
- Leak/Splash50
- Loss of or Failure to Bond50
- Infusion or Flow Problem27
- Fluid/Blood Leak10
- Device Handling Problem5
- Material Deformation5
Patient problems
- No Clinical Signs, Symptoms or Conditions168
- Hyperglycemia156
- Elevated Ketones/ Diabetic Ketoacidosis22
- Hemorrhage/Blood Loss/Bleeding5
- Skin Inflammation/ Irritation5
- No Known Impact Or Consequence To Patient4
- Pain3
- Hypoglycemia2
Recent adverse event reports
The 25 most recent of 359 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced detachment of Infusion Set while using event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912559 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821175 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821170 ↗InjurySep 18, 2026Fluid/Blood Leak
Patient problems: Hyperglycemia
MAUDE report 50821097 ↗MalfunctionSep 5, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50632282 ↗InjuryAug 30, 2026Device Handling Problem
Patient problems: Hyperglycemia
MAUDE report 50514647 ↗MalfunctionAug 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50512903 ↗InjuryAug 26, 2026Leak/Splash
It was reported by the patient that infusion set tubing was leaking at the site on (b)(6) 2024 and patient experienced high blood glucose level and treated with Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50450104 ↗MalfunctionAug 25, 2026Leak/Splash
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50439683 ↗MalfunctionAug 25, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50427421 ↗InjuryAug 21, 2026Leak/Splash
It was reported that patient faced an infusion set tubing leak at site event on (b)(6) 2024 which led to high blood glucose and it was treated with Correction injection via pump.
Patient problems: Hyperglycemia
MAUDE report 50370046 ↗MalfunctionAug 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50293642 ↗MalfunctionAug 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50293640 ↗MalfunctionAug 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50293613 ↗MalfunctionAug 17, 2026Leak/Splash
It was reported that the patient experienced an infusion set tubing leakage at the site on (b)(6) 2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280557 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280554 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280550 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280301 ↗MalfunctionAug 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185813 ↗MalfunctionAug 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185093 ↗MalfunctionAug 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185090 ↗MalfunctionAug 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185089 ↗MalfunctionAug 8, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50185079 ↗InjuryAug 4, 2026Leak/Splash
It was reported that the patient experienced an issue in which the infusion set tubing was leaking at the site which led to hyperglycemia and was treated with Correction bolus via Pump on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50125047 ↗InjuryAug 4, 2026Leak/Splash
It was reported that the patient experienced an issue in which the infusion set tubing was leaking at the site which led to hyperglycemia and was treated with Correction bolus via Pump on (b)(6) 2025.
Patient problems: Hyperglycemia
MAUDE report 50125045 ↗
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.