inset™ 100-182-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244006935), received between Apr 16, 2019 and Apr 23, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (4 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

Recent adverse event reports

The 4 most recent of 4 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 THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED KINKED CANNULA ISSUE DUE TO WHICH SHE EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE BETWEEN 453 MG/DL AND 550 MG/DL. THIS WAS SELF-TREATED BY DELIVERING A BOLUS AND INJECTION. THEY CHANGED THE SITE OUT AND HER BLOOD GLUCOSE LEVEL HAD COME DOWN. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE SHE RECEIVED INSULIN AND FLUIDS, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND THE INFUSION SET HAD BEEN IN USE FOR LESS THAN A DAY. 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 8539316 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT FACED BENT CANNULA ISSUES WITH 6-8 INFUSION SETS. THIS RESULTED IN HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE BETWEEN 200 MG/DL AND 300 MG/DL, AT THE TIME OF THIS EVENT. IT WAS SELF-TREATED WITH A BOLUS AND MANUAL CORRECTIONS. THE PATIENT ALSO CHANGED THE SITE. THE PATIENT ALSO TESTED POSITIVE FOR LARGE KETONE AND THE LEVEL OF KETONES WAS IDENTIFIED TO BE DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS 588 MG/DL. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE PATIENT RECEIVED INSULIN AND SALINE VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. INFUSION SET HAD BEEN IN USE FOR ONE AND A HALF DAY. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT STAYED IN THE HOSPITAL 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 DU

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8539224 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED BENT CANNULA ISSUES TWICE DUE TO WHICH THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH WAS SELF-TREATED WITH CORRECTION BOLUSES AND BY CHANGING SITES. SINCE THE CORRECTION BOLUSES DID NOT BRING THE BLOOD SUGAR LEVEL DOWN, THE PATIENT WENT TO THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE LEVEL BETWEEN 500 MG/DL AND 600 MG/DL. FURTHERMORE, THE PATIENT HAD LARGE KETONES WITH ITS LEVEL IDENTIFIED AS DANGEROUS/LIFE THREATENING BY A HEALTHCARE PROFESSIONAL. HIGHEST BLOOD GLUCOSE LEVEL REPORTED WAS IN 600S MG/DL. THE PATIENT WAS GIVEN INSULIN VIA INTRAVENOUS ROUTE AND GLUCOSE. THE PATIENT STAYED THERE FOR A FEW HOURS AND WAS STABLE WHEN THE PATIENT LEFT THE EMERGENCY ROOM. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE THE PATIENT RECEIVED INSULIN VIA INTRAVENOUS ROUTE AND GLUCOSE, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR 48 HOURS. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8539119 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED AN ISSUE WITH THE INFUSION SET IN THE FORM OF BENT CANNULA AND IT WAS NOTED AFTER THE REMOVAL OF THE SET. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE WAS 586 MG/DL, EXPERIENCED DIABETIC KETOACIDOSIS (LARGE KETONES) AND HAD ABDOMINAL PAIN. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE INTRAVENOUS FLUIDS AND INSULIN VIA INJECTION WAS GIVEN. THE PATIENT WAS BEING 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 8517501 ↗