Autosoft90™ 1002818Recalls & 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 is a single-use infusion set for subcutaneous use. Of the 601 reports naming it, many describe tubing that is twisted or bent, bonds failing and parts separating early, and many patients report high blood glucose after problems with the set. The reports include 99 injuries and no deaths, and reports rose from 140 in the previous 12 months to 211 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
- 683
- Deaths reported
- 0
- Injuries reported
- 153
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 683 adverse event reports that list this exact device (DI 05705244018150), received between Feb 5, 2021 and Sep 30, 2026 — classified as 153 injuries, 530 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (222 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/Bent222
- Loss of or Failure to Bond151
- Premature Separation94
- Detachment of Device or Device Component62
- Leak/Splash61
- Complete Blockage39
- Infusion or Flow Problem32
- Material Deformation31
Patient problems
- No Clinical Signs, Symptoms or Conditions371
- Hyperglycemia283
- Elevated Ketones/ Diabetic Ketoacidosis21
- Pain4
- Hemorrhage/Blood Loss/Bleeding3
- Coma1
- Skin Inflammation/ Irritation1
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 683 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging
It was reported that the patient faced an event where infusion sets boxes were damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944138 ↗MalfunctionSep 30, 2026Tear, Rip or Hole in Device Packaging
It was reported that the patient faced an event where infusion sets boxes were damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944132 ↗InjurySep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site with three infusion sets over approximately one and a half months, resulting in hyperglycemia and was treated with correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50941834 ↗InjurySep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site with three infusion sets over approximately one and a half months, resulting in hyperglycemia and was treated with correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50941833 ↗InjurySep 30, 2026Fluid/Blood Leak
It was reported that the patient experienced infusion set tubing leakage at the infusion site with three infusion sets over approximately one and a half months, resulting in hyperglycemia and was treated with correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50941832 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient had high blood glucose 500 mg/dL (27.7 mmol/L) due to that seven-infusion set patch did not stick to skin upon insertion and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50917875 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient had high blood glucose 500 mg/dL (27.7 mmol/L) due to that seven-infusion set patch did not stick to skin upon insertion and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50917872 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient had high blood glucose 500 mg/dL (27.7 mmol/L) due to that seven-infusion set patch did not stick to skin upon insertion and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50917870 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient had high blood glucose 500 mg/dL (27.7 mmol/L) due to that seven-infusion set patch did not stick to skin upon insertion and treated with Correction injection via Multiple daily injection on (b)(6)2026
Patient problems: Hyperglycemia
MAUDE report 50917867 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient had high blood glucose 500 mg/dL (27.7 mmol/L) due to that seven-infusion set patch did not stick to skin upon insertion and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50917866 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the Patient had high blood glucose 500 mg/dL (27.7 mmol/L) due to that seven-infusion set patch did not stick to skin upon insertion and treated with Correction injection via Multiple daily injection on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50917864 ↗InjurySep 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: Hyperglycemia
MAUDE report 50917837 ↗InjurySep 26, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50906898 ↗MalfunctionSep 24, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50881475 ↗InjurySep 24, 2026Complete Blockage
It was reported that the patient had a high glucose level on (b)(6) 2026 due to blockage was likely at the site. The patient was treated with multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50880391 ↗InjurySep 24, 2026Complete Blockage
It was reported that the patient had a high glucose level on (b)(6) 2026 due to blockage was likely at the site. The patient was treated with multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50880369 ↗MalfunctionSep 24, 2026Partial Blockage
It was reported that patient faced occlusion troubleshooting indicated issue with the infusion set site and the infusion set was inserted on abdomen. The patient noticed after three or more hours of insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50880229 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an event where an hyperglycemia treated with Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50877794 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced infusion flow block along with high blood glucose which was addressed by correction injection via Multiple daily injection event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50866894 ↗InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available
It was reported that patient experienced infusion flow block along with high blood glucose which was addressed by correction injection via Multiple daily injection event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50866890 ↗InjurySep 22, 2026Complete Blockage; Material Twisted/Bent
It was reported that patient experienced high blood glucose levels 17.5 mmol/L due to kinked cannula and was treated with bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50855012 ↗InjurySep 20, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50834601 ↗InjurySep 20, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50834159 ↗InjurySep 20, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50834158 ↗InjurySep 20, 2026Complete Blockage; Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50834157 ↗
Other Set, Administration, Intravascular devices
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- 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.