inset™ 100-181-03Recalls & 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
All models of inset (13)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244006928), received between Jan 23, 2019 and Jan 23, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
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.
MalfunctionJan 23, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER STATED THAT WHILE SLEEPING AT NIGHT, THE TUBING DETACHED AT THE CLIP. SHE ALSO REPORTED THAT THERE WAS NO DAMAGE TO THE TUBING OR THE CLIP. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS IN HIGH 300'S MG/DL AND HAD MODERATE LEVEL OF KETONES. REPORTEDLY, THE PATIENT EXPERIENCED NAUSEA, VOMITING AND ABDOMINAL PAIN BUT REMAINED ON THE PUMP. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8269722 ↗
Other Set, Administration, Intravascular devices
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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