inset 30 100-396-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05705244007123), received between Jan 11, 2019 and Apr 23, 2019 — classified as 2 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 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. THE PATIENT REPORTED HAVING FACED BENT CANNULA ISSUE THAT CAUSED HIGH BLOOD GLUCOSE LEVEL, WHICH WAS SELF-TREATED WITH BOLUS FROM THE PUMP AND MANUAL INJECTION. THEREAFTER, THE PATIENT WENT TO THE EMERGENCY ROOM AND UPON ADMISSION, PATIENT'S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 400 MG/DL. THE PATIENT ALSO HAD LARGE KETONES AND THE LEVEL OF KETONES WAS NOT IDENTIFIED AS DANGEROUS/LIFE THREATENING BY THE HEALTHCARE PROFESSIONAL. THE PATIENT RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN DRIP AS CORRECTIVE TREATMENT. THE PATIENT STAYED IN THE EMERGENCY ROOM FOR A FEW HOURS. THE PATIENT STILL EXPERIENCED ELEVATED BLOOD GLUCOSE LEVEL THAT REQUIRED ATTENTION AND SHOWED SIGNS OF DIABETIC KETOACIDOSIS DUE TO WHICH, SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED. THE PATIENT RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN DRIP, WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR APPROXIMATELY ONE DAY. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT AND THE PATIENT STAYED IN THE HOSPITAL FOR FIVE DAYS. THE PATIENT PERFORMED A SUPPLY CHANGE AND RESUMED INSULIN FROM THE PUMP AFTER BEING RELEASED FROM THE HOSPITA

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8539211 ↗
• MalfunctionJan 21, 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, THE HOSE WAS NOT GLUED TO THE CONNECTOR PART. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8265837 ↗
• InjuryJan 11, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE. SHE STATED ISSUES WITH INFUSION SET IN THE FORM OF KINKED CANNULA. PRIOR TO HOSPITALIZATION, SHE TRIED CORRECTING HER BLOOD GLUCOSE LEVEL WITH CORRECTION BOLUS AND MDI BUT IT STILL DID NOT CAME DOWN. SUBSEQUENTLY, SHE WAS TAKEN TO EMERGENCY ROOM (ER), WHERE SHE STAYED FOR MORE THAN 6 HOURS, HER BLOOD GLUCOSE LEVEL WAS 1179 MG/DL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS FOLLOWING WHICH SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS GIVEN INTRAVENOUS DRIP, INSULIN DRIP AND A SODIUM BICARBONATE FLUSH AS A CORRECTIVE TREATMENT. REPORTEDLY, THE PATIENT WAS USING INFUSION SET FOR LESS THAN A DAY. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. SHE ALSO STATED, THAT SHE INSERTED THE CANNULA IN SCAR TISSUE AND IT WAS FOUND TO BE KINKED. 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 8238774 ↗