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inset™ 100-181-02Recalls & 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 05705244006942), received between Apr 22, 2019 and Apr 23, 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 23, 2019Material Twisted/Bent; Material Twisted/Bent

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S CANNULA WAS BENT. REPORTEDLY, HER BLOOD GLUCOSE WAS IN THE RANGE OF 1000 MG/DL AND HAD EXPERIENCED DIABETIC KETOACIDOSIS. SHE SELF-TREATED WITH A CORRECTION BOLUS VIA PUMP AND MULTIPLE DAILY INJECTION. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL AND RECEIVED INTRAVENOUS INSULIN AND SOME UNSPECIFIED FLUIDS WHICH RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR FOUR DAYS. IT WAS REPORTED THAT SHE HAD A HEART ATTACK BECAUSE OF THIS EVENT. 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 8538758 ↗
  • InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED KINKED CANNULA ISSUE AFTER THE REMOVAL OF THE SET. REPORTEDLY THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 800 MG/DL AND HAD POSITIVE AND LARGE KETONES. SHE WAS CONFUSED WHICH WAS A SYMPTOM OF HER HIGH BLOOD GLUCOSE LEVELS. SUBSEQUENTLY, SHE WAS HOSPITALIZED AND RECEIVED INSULIN AS CORRECTIVE TREATMENT. SHE REMAINED ON THE PUMP AND WAS HOSPITALIZED FOR THREE 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 8538426 ↗

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Sources and updates

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