Autosoft30™ 1000202Recalls & reported problems
Unomedical A/S · Single use infusion tubing for subcutaneous infusion. The infusion tubing must be used as described in the instruction for use. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244014633), received between Jun 10, 2019 and Jun 10, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).
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.
Most reported problems
Device problems
- Material Twisted/Bent1
Patient problems
- Elevated Ketones/ Diabetic Ketoacidosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 10, 2019Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT VISITED THE EMERGENCY ROOM AS SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 546 MG/DL AT THE TIME OF ARRIVAL. THE PATIENT RECEIVED INSULIN INJECTIONS, FLUIDS VIA INTRAVENOUS ROUTE AND SPENT 12 HOURS IN THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 441 MG/DL AND WAS STILL NOT FEELING WELL WHEN SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR DIABETIC KETOACIDOSIS. SHE HAD KETONE LEVELS WHICH THE HEALTH CARE PROFESSIONAL ASSESSED AS DANGEROUS/LIFE THREATENING. THE CANNULA WAS KINKED WHEN INSPECTED UPON REMOVAL AND THE PATIENT ALSO HAD COLD WHICH SHE BELIEVED TO HAVE CONTRIBUTED TO HIGH BLOOD GLUCOSE LEVEL. SHE RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY 24 HOURS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE WAS HOSPITALIZED FOR TWO DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CA
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8682156 ↗
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.