inset™II 100-410-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05705244007413), received between Mar 18, 2019 and Apr 23, 2019 — classified as 1 injury, 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 18, 2026.

Most reported problems

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 (B)(6). IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVEL (600 MG/DL). THE PATIENT HAD SYMPTOMS INCLUDING NAUSEA, VOMITING, KETONES PRESENT, UNSTEADINESS WHEN STANDING OR WALKING, SEVERE DIZZINESS, LIGHT-HEADEDNESS, SEVERE HEADACHE, EXTREME THIRST, EXCESS URINATION, SYMPTOMS OF DEHYDRATION, RAPID DEEP BREATHING, SHORTNESS OF BREATH, ABDOMINAL PAIN AND CHEST PAIN. DURING HOSPITALIZATION, THE PATIENT RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN INJECTION. IN THE HOSPITAL, THE PUMP AND THE INFUSION SET WERE TAKEN AWAY. THE HEALTH CARE PROFESSION HAD NOTICED THAT THE INSERTION SITE WAS WET AND THE INFUSION SET HAD A BENT CANNULA. TWO DAYS LATER, THE PATIENT RESTARTED USING PUMP BUT REMAINED IN THE HOSPITAL. UNTIL THAT DAY, THE HEALTHCARE PROFESSION DELIVERED INSULIN WITH PEN AND INTRAVENOUS FLUID. PATIENT'S BLOOD GLUCOSE LEVEL WAS 98 MG/DL. FOUR DAYS AFTER HOSPITALIZATION, THE PATIENT WAS STILL IN THE HOSPITAL WITH DECREASED BLOOD GLUCOSE LEVEL. 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 INFUSI

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8538571 ↗
• MalfunctionMar 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT IN ONE OF HIS INFUSION SETS, THE TUBING CAME AWAY FROM THE ANCHOR AT THE CLIP PART THAT HAD THE NEEDLE DUE TO WHICH HIS BLOOD GLUCOSE LEVEL REACHED 24 MMOL/L WITHOUT HIM REALIZING. THIS HAD OCCURRED A FEW TIMES WHILE THE PATIENT WAS ASLEEP IN BED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8427498 ↗