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inset™ 100-182-01Recalls & 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244006836), received between Dec 12, 2018 and Apr 22, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Material Twisted/Bent2

Patient problems

  • Elevated Ketones/ Diabetic Ketoacidosis2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT THE SON FACED BENT CANNULA ISSUE DUE TO WHICH HE DID NOT GET INSULIN. HE EXPERIENCED VOMITING, STOMACH CRAMPS, BACK PAIN AND WAS UNABLE TO MOVE. HE WAS TAKEN TO THE EMERGENCY ROOM WHERE HE WAS MONITORED, GIVEN MEDICINES AND FLUIDS TO BRING HIS BLOOD GLUCOSE LEVEL DOWN FROM 800 MG/DL. SUBSEQUENTLY, HE WAS ADMITTED TO THE HOSPITAL WHERE HE RECEIVED INTRAVENOUS FLUIDS AS CORRECTIVE TREATMENT. WHEN THEY HAD HIM REMOVE HIS INFUSION SET, THE CANNULA WAS FOUND TO BE BENT. THE PATIENT STAYED IN THE HOSPITAL FOR TWO DAYS AND HAD RESUMED WITH SAME PUMP. 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 CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

    MAUDE report 8535036 ↗
  • InjuryDec 12, 2018Material Twisted/Bent; Material Twisted/Bent

    (B)(4) EVENT OCCURRED IN UNITED STATES. THE PATIENT'S MOTHER STATED THAT THE INFUSION SET HAD BENT CANNULA AND WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE PATIENT REPORTED SIGNS AND SYMPTOMS OF VOMITING, NAUSEA AND WAS GROUCHY. THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 500 MG/DL WITH LARGE KETONES. THE PATIENT RECEIVED INTRAVENOUS FLUIDS, INSULIN DROP, CALCIUM DROPS AND SOME UNSPECIFIED INTRAVENOUS DROP AS CORRECTIVE TREATMENT. THE PATIENT 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 CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

    MAUDE report 8154361 ↗

Other Set, Administration, Intravascular devices

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Sources and updates

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