Autosoft XC 1001682Recalls & 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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Autosoft XC infusion set delivers medication under the skin. Its 461 reports mostly describe tubing that twists, bends or kinks, adhesive failures and sets coming loose, and many also mention high blood sugar. The reports include no deaths and 96 injuries. 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
- 468
- Deaths reported
- 0
- Injuries reported
- 101
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 468 adverse event reports that list this exact device (DI 05705244016682), received between Sep 17, 2019 and Sep 23, 2026 — classified as 101 injuries, 367 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (256 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/Bent256
- Loss of or Failure to Bond45
- Detachment of Device or Device Component39
- Infusion or Flow Problem30
- Premature Separation23
- Complete Blockage18
- Leak/Splash18
- Use of Incorrect Control/Treatment Settings14
Patient problems
- No Clinical Signs, Symptoms or Conditions225
- Hyperglycemia164
- Elevated Ketones/ Diabetic Ketoacidosis60
- Hemorrhage/Blood Loss/Bleeding10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Localized Skin Lesion4
- Abdominal Pain1
- Dehydration1
Recent adverse event reports
The 25 most recent of 468 reports, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Fluid/Blood Leak
It was reported that the patient faced leakage at the infusion set tubing at the site, leading to high blood glucose, and was treated with a correction bolus via pump on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50864318 ↗InjurySep 23, 2026Fluid/Blood Leak
It was reported that the patient faced leakage at the infusion set tubing at the site, leading to high blood glucose, and was treated with a correction bolus via pump on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50864317 ↗InjurySep 23, 2026Fluid/Blood Leak
It was reported that the patient faced leakage at the infusion set tubing at the site, leading to high blood glucose, and was treated with a correction bolus via pump on (b)(6)2026.
Patient problems: Hyperglycemia
MAUDE report 50864305 ↗InjuryAug 26, 2026Complete Blockage
It was reported that the patient experienced a kinked infusion set cannula on(b)(6)2026. The issue caused the patient¿s blood glucose to display high, and the patient addressed the high blood glucose with a correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50459751 ↗MalfunctionAug 25, 2026Loss of or Failure to Bond; Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435923 ↗MalfunctionAug 24, 2026Leak/Splash
It was reported that the patient faced an event where infusion set tubing was leaking at the site on (b)(6) 2024.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50402417 ↗InjuryAug 19, 2026Fluid/Blood Leak
It was reported that the patient faced infusion set tubing was leaking at the site event on (b)(6) 2025 and also experienced high blood glucose levels which was treated by Correction injection via MDI.
Patient problems: Hyperglycemia
MAUDE report 50317737 ↗MalfunctionAug 17, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50280731 ↗InjuryAug 6, 2026Leak/Splash
It was reported that patient faced infusion set tubing was leaking at the site issue on (b)(6) 2025. The patient experienced high blood glucose levels and event was resolved by Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50151881 ↗MalfunctionAug 6, 2026Premature Separation
It was reported that the patient faced the infusion set falling off during use due to an adhesive issue on (b)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151790 ↗MalfunctionAug 6, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151788 ↗InjuryAug 6, 2026Leak/Splash
It was reported that patient faced infusion set tubing was leaking at the site issue on (b)(4)2025. The patient experienced high blood glucose levels and event was resolved by Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50151779 ↗MalfunctionAug 6, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151758 ↗MalfunctionAug 6, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151755 ↗MalfunctionAug 6, 2026Premature Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151744 ↗InjuryAug 6, 2026Leak/Splash
It was reported that patient faced infusion set tubing was leaking at the site issue on (b)(6) 2025. The patient experienced high blood glucose levels and event was resolved by Correction bolus via pump.
Patient problems: Hyperglycemia
MAUDE report 50151731 ↗MalfunctionAug 5, 2026Complete Blockage
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139936 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117902 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117826 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117824 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117823 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117821 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117820 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
It was reported that the patient infusion set leaking at site on (b)(6)2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117818 ↗MalfunctionAug 3, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50117335 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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