Autosoft XC 1010900Recalls & 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 set for subcutaneous infusion. Many of the 1,359 reports describe the tubing twisting or bending, parts failing to bond, or leaks, and some describe high blood sugar after leaking tubing. Hyperglycemia is listed as a patient problem in 653 reports. The reports include no deaths and 80 injuries. Reports fell from 445 in the prior 12 months to 123 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
- 1,395
- Deaths reported
- 0
- Injuries reported
- 90
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1,395 adverse event reports that list this exact device (DI 05705244026018), received between Mar 11, 2024 and Sep 30, 2026 — classified as 90 injuries, 1,305 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (857 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/Bent857
- Loss of or Failure to Bond215
- Infusion or Flow Problem92
- Leak/Splash84
- Detachment of Device or Device Component61
- Premature Separation41
- Fluid/Blood Leak20
- Device Handling Problem14
Patient problems
- Hyperglycemia664
- No Clinical Signs, Symptoms or Conditions656
- Elevated Ketones/ Diabetic Ketoacidosis42
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Hemorrhage/Blood Loss/Bleeding11
- Hypoglycemia4
- Abdominal Pain2
- Hypersensitivity/Allergic reaction2
Recent adverse event reports
The 25 most recent of 1,395 reports, in the reporter's own words as published by the FDA.
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 tape was not sticking.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944542 ↗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 50943742 ↗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 and (b)(6)-2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943739 ↗MalfunctionSep 30, 2026Detachment of Device or Device Component
It was reported that the patient experienced an event on (b)(6) 2026 where adhesive patch detached from cannula housing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942516 ↗MalfunctionSep 27, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50909848 ↗MalfunctionSep 27, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909517 ↗MalfunctionSep 27, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50909506 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907225 ↗MalfunctionSep 26, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906946 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced tubing getting caught in applicator during infusion set deployment, and also experienced high blood glucose level and treated with Correction injection via Multiple daily injections
Patient problems: Hyperglycemia
MAUDE report 50896145 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced tubing getting caught in applicator during infusion set deployment, and also experienced high blood glucose level and treated with Correction injection via Multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50896141 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced tubing getting caught in applicator during infusion set deployment, and also experienced high blood glucose level and treated with Correction injection via Multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50896065 ↗InjurySep 25, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced tubing getting caught in applicator during infusion set deployment, and also experienced high blood glucose level and treated with Correction injection via Multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50896055 ↗MalfunctionSep 25, 2026Partial Blockage
It was reported that patient received occlusion alarm on (b)(6) 2026 and occlusion troubleshooting indicated issue with the infusion set site.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894737 ↗MalfunctionSep 23, 2026Use of Incorrect Control/Treatment Settings
It was reported that patient experienced an issue on (b)(6) 2026 where infusion set was accidentally pulled out during use due to tubing catching on something or pump falling.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865511 ↗MalfunctionSep 23, 2026Detachment of Device or Device Component
It was reported that patient experienced adhesive patch and cannula housing detached from spring prior to insertion which led to cannula bent on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864012 ↗MalfunctionSep 20, 2026Leak/Splash; Deformation Due to Compressive Stress
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50834098 ↗MalfunctionSep 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50825409 ↗MalfunctionSep 18, 2026Use of Incorrect Control/Treatment Settings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50823390 ↗InjurySep 16, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient faced an event with infusion set where infusion set cannula is kinked on (b)(6)2026 and patient also reported high blood glucose levels of 303 mg/dl and treated with correction injection via multiple daily injections.
Patient problems: Hyperglycemia
MAUDE report 50787329 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond; Detachment of Device or Device Component; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770159 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond; Detachment of Device or Device Component; Premature Separation
It was reported that patient experienced adhesive and cannula issues because infusion set adhesive patch and cannula housing detached from spring prior to insertion during needle guard removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770157 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond; Detachment of Device or Device Component; Premature Separation
It was reported that patient experienced adhesive and cannula issues because infusion set adhesive patch and cannula housing detached from spring prior to insertion during needle guard removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770156 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond; Detachment of Device or Device Component; Premature Separation
It was reported that patient experienced adhesive and cannula issues because infusion set adhesive patch and cannula housing detached from spring prior to insertion during needle guard removal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50770153 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond; Premature Separation
It was reported that the patient experienced an infusion set fell off event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50769237 ↗
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- 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.