Autosoft30™ 1000283Recalls & 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 medication under the skin. Its 332 reports mostly describe kinked or bent tubing, sets that do not stay attached and blockages, with high blood sugar mentioned in many patients. The reports mention 44 injuries and no deaths. 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
- 335
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 335 adverse event reports that list this exact device (DI 05705244014664), received between Apr 16, 2019 and Sep 18, 2026 — classified as 44 injuries, 291 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (131 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/Bent131
- Loss of or Failure to Bond64
- Detachment of Device or Device Component50
- Premature Separation21
- Leak/Splash19
- Infusion or Flow Problem16
- Complete Blockage14
- Use of Incorrect Control/Treatment Settings12
Patient problems
- No Clinical Signs, Symptoms or Conditions190
- Hyperglycemia118
- Elevated Ketones/ Diabetic Ketoacidosis17
- Erythema3
- Hot Flashes/Flushes3
- Local Reaction3
- Skin Infection3
- Skin Inflammation/ Irritation3
Recent adverse event reports
The 25 most recent of 335 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50821099 ↗MalfunctionSep 6, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50637283 ↗MalfunctionSep 4, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced infusion set fell off during use on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50611462 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced high blood glucose and treated with insulin via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50608675 ↗InjurySep 4, 2026Appropriate Device Problem Term/Code Not Available
Patient reported an event of high blood glucose level due to occlusion with inconclusive troubleshoot, which was treated by corrective bolus.
Patient problems: Hyperglycemia
MAUDE report 50607591 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose level which was treated by Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50604117 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that patient experienced high blood glucose level which was treated by Correction injection via MDI on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50604074 ↗MalfunctionSep 2, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50558931 ↗InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Hyperglycemia
MAUDE report 50558618 ↗MalfunctionAug 31, 2026Partial Blockage
It was reported that there was blockage is at site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50515489 ↗MalfunctionAug 30, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50514612 ↗MalfunctionAug 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: Skin Infection
MAUDE report 50512124 ↗MalfunctionAug 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: Skin Infection
MAUDE report 50512062 ↗MalfunctionAug 30, 2026Partial Blockage; Material Twisted/Bent
Patient problems: Skin Infection
MAUDE report 50511905 ↗MalfunctionAug 30, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510474 ↗MalfunctionAug 30, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50510437 ↗MalfunctionAug 28, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502774 ↗InjuryAug 28, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient faced Hyperglycemia treated with corrective injection via Multiple dose injection and experienced an infusion set cannula kinked event which leads to occlusion on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50499163 ↗MalfunctionAug 27, 2026Fluid/Blood Leak
It was reported that there was leakage infusion set tubing was leaking at the site and elevated blood glucose on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50476685 ↗MalfunctionAug 27, 2026Use of Incorrect Control/Treatment Settings
It was reported that the patient experienced hyperglycemia and had an event involving infusion set was accidentally pulled out during use due to tubing caught on something or pump falling.
Patient problems: Hyperglycemia
MAUDE report 50473054 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced two infusion sets fell off during use event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50472129 ↗MalfunctionAug 27, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient faced two infusion sets fell off during use event on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50472097 ↗InjuryAug 27, 2026Device Handling Problem
It was reported that patient misused the infusion set as patient inserted the infusion set into the scar tissue, patient did not rotate the site and lumps are seen at the site of insertion and the patient also experienced hyperglycemia (362 mg/dl) event on(b)(6)2026 and was treated with Manual daily injections.
Patient problems: Hyperglycemia
MAUDE report 50469266 ↗MalfunctionAug 26, 2026Loss of or Failure to Bond; Premature Separation
It was reported that patient has experienced infusion set fall of on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457983 ↗MalfunctionAug 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457976 ↗
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.