inset™ 100-182-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05705244006874), received between Dec 28, 2018 and Apr 26, 2019 — classified as 23 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (20 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• InjuryApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE WENT INTO DIABETIC KETOACIDOSIS WITH THE HIGHEST BLOOD GLUCOSE LEVEL REPORTED AS 614 MG/DL, WHICH WAS SELF-TREATED WITH A CORRECTIVE BOLUS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED WHERE SHE RECEIVED LANTUS AS CORRECTIVE TREATMENT, WHICH RESOLVED THE ISSUE. THE PATIENT LATER NOTICED THAT THE NEEDLE WAS NOT STRAIGHT. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS AND 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 DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8554342 ↗
• InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT RECEIVED AN OCCLUSION ALARM AND BLOOD GLUCOSE LEVEL WAS 900 MG/DL AT THE TIME OF OCCLUSION. HE WAS ADMITTED TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL AND REALIZED THAT THE CANNULA WAS BENT, NOT RECEIVING INSULIN. THE INFUSION SET HAD BEEN IN USE FOR 2 DAYS. THE PATIENT RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. HE WAS HOSPITALIZED FOR 2 DAYS. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 226 MG/DL AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8548813 ↗
• InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT HAD BENT CANNULA AND WENT TO THE EMERGENCY DUE TO BEING UNCONSCIOUS FROM CARDIAC ARREST AND PATIENT STATED IT WAS DUE TO HIGH BLOOD GLUCOSE LEVEL. THE PATIENT STATED THAT HE RECEIVED CARDIO-PULMONARY RESUSCITATION BEFORE BEING TRANSPORTED TO THE EMERGENCY. HIS BLOOD GLUCOSE LEVEL WAS IN 700S MG/DL WHEN HE ARRIVED AT THE EMERGENCY ROOM. THE PATIENT ALSO HAD KETONE LEVELS. HE SELF-TREATED HIMSELF WITH BOLUS VIA PUMP PRIOR TO BEING UNCONSCIOUS AND BEING TRANSPORTED TO THE EMERGENCY. HE WAS IN THE EMERGENCY ROOM FOR LESS THAN A DAY AND RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. DURING HOSPITALIZATION, WHEN HIS CANNULA WAS REMOVED IT WAS BENT. HE WAS TREATED WITH INTRAVENOUS FLUIDS AND INSULIN WHICH RESOLVED THE ISSUE. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY. DUE TO THIS EVENT HE HAD TO HAVE A CARDIAC DEFIBRILLATOR SURGICALLY IMPLANTED INTO HIS BODY. HE WAS HOSPITALIZED FOR 10 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 AN

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8548560 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET'S CANNULA WAS BENT. REPORTEDLY, THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. THE PATIENT WAS IMMEDIATELY ADMITTED TO THE HOSPITAL, WHERE INTRAVENOUS INSULIN DRIP WAS GIVEN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE. 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 8543048 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET CANNULA WAS BENT. REPORTEDLY, THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS AND EXPERIENCED DIABETIC KETOACIDOSIS, WHICH WAS SELF-TREATED WITH A CORRECTION BOLUS VIA THE PUMP. SUBSEQUENTLY, THE PATIENT RECEIVED INTRAVENOUS INSULIN DRIP AND SOME UNSPECIFIED FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR A FEW DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 8542896 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET CANNULA WAS KINKED. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE WAS HIGH AND EXPERIENCED SYMPTOMS OF DIABETIC KETOACIDOSIS, WHICH WERE SELF-TREATED WITH A CORRECTION BOLUS BY THE PUMP. UPON ARRIVAL IN THE EMERGENCY ROOM, THE PATIENT'S BLOOD GLUCOSE LEVELS WERE 450 MG/DL, WHERE THE STAY WAS FOR FEW HOURS AND WAS GIVEN INSULIN DRIP AND SOME UNSPECIFIED FLUIDS. THE PATIENT LEFT THE EMERGENCY ROOM, WHEN BLOOD GLUCOSE LEVEL WAS AROUND 400 MG/DL AND WAS STILL UNSTABLE. SUBSEQUENTLY, THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT AND WAS GIVEN INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR ONE DAY. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 8542881 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET CANNULA WAS KINKED. REPORTEDLY, HER BLOOD GLUCOSE LEVEL WAS 200 MG/DL, WHICH SHE SELF-TREATED WITH A BOLUS BUT IT STILL INCREASED. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL AND WAS GIVEN SOME UNSPECIFIED FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO HER. 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 8542849 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET CANNULA WAS BENT. REPORTEDLY, SHE CHANGED THE SITE IN THE NIGHT AND BUT THE VERY NEXT MORNING, AFTER SHE WOKE UP, HER BLOOD GLUCOSE WAS AT 540 MG/DL, HAD TRACES OF KETONES AND SHE WAS THROWING UP. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL AND THE HEALTH CARE PROFESSIONAL MIGHT CONSIDER THE KETONE LEVEL AS DANGEROUS OR LIFE THREATENING. DURING THE TREATMENT AT THE HOSPITAL, IT WAS FOUND THAT THE SITE WAS BENT UNDERNEATH HER SKIN. SHE WAS GIVEN INTRAVENOUS DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR ONE NIGHT ONLY. THE PATIENT WAS HOSPITALIZED FOR FOUR DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE HER. 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 8542789 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED HAVING EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH WAS SELF-TREATED WITH A CORRECTION BOLUS. THE PATIENT WENT TO THE EMERGENCY ROOM WITH BLOOD GLUCOSE LEVEL AT 575 MG/DL AND THE PATIENT ALSO HAD KETONES. THE PATIENT RECEIVED INSULIN VIA INTRAVENOUS ROUTE IN THE EMERGENCY ROOM. THE PATIENT WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL WHERE THE PATIENT RECEIVED INSULIN VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. UPON CHECKING THE SITE IN THE HOSPITAL, SHE IDENTIFIED THAT THE CANNULA WAS BENT. THE INFUSION SET HAD BEEN IN USE FOR ONE DAY AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS. SHE HAD CHANGED THE CARTRIDGE AND INFUSION SET AFTER SHE WAS RELEASED FROM THE HOSPITAL AND RESUMED INSULIN ON THE 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 8539273 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT THE INFUSION SET'S CANNULA WAS BENT. REPORTEDLY, THE PATIENT'S BLOOD GLUCOSE WAS 662 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS (KETONE LEVEL WAS 7.2 MMOL/L). THE PATIENT SELF-TREATED WITH A CORRECTIVE BOLUS. SUBSEQUENTLY, THE PATIENT WAS ADMITTED IN THE HOSPITAL, WHERE INSULIN DRIP WAS GIVEN AS A CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 8538623 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. THE PHYSICIAN'S ASSISTANT REPORTED THAT THE INFUSION SET'S CANNULA WAS BENT. IT WAS NOTICED WHEN THE PATIENT REMOVED THE SITE WHICH SHE USED DURING HIGH BLOOD GLUCOSE LEVELS. REPORTEDLY, HER BLOOD GLUCOSE WAS OVER 600 MG/DL PRIOR GOING TO THE HOSPITAL AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SHE SELF-TREATED WITH MULTIPLE DAILY INJECTIONS AND CHANGED THE SITE TWICE. SUBSEQUENTLY, SHE WAS ADMITTED IN THE HOSPITAL, WHERE THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS AND LIFE THREATENING. SHE RECEIVED INSULIN DRIP, SUBCUTANEOUS INSULIN, LANTUS (INSULIN GLARGINE) AND LIPOZENE AS CORRECTIVE TREATMENT. SHE WAS CURRENTLY ON INJECTIONS AND DRIP, BUT THE ISSUE WAS NOT FULLY RESOLVED. SHE WAS HOSPITALIZED FOR THREE DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. MOREOVER, SHE HAD STARTED TO USE PENS SINCE THEN. THE PATIENT'S BLOOD GLUCOSE WAS REPORTED TO BE 321 MG/DL AFTER ONE DAY OF HOSPITALISATION. 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,

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8538575 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT HER INFUSION SET'S CANNULA WAS KINKED AND DID NOT RECEIVE INSULIN. REPORTEDLY, HER BLOOD GLUCOSE WAS IN THE RANGE OF 500-600 MG/DL AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SHE TRIED TO CHANGE HER SUPPLIES BUT WAS TOO LATE BECAUSE HER BLOOD GLUCOSE LEVELS WENT VERY HIGH. SUBSEQUENTLY, SHE WAS ADMITTED IN THE HOSPITAL, WHERE SHE RECEIVED INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR TWO DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR ONE 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 8538565 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT HER INFUSION SET'S CANNULA WAS KINKED. REPORTEDLY, HER BLOOD GLUCOSE WAS MORE THAN 600 MG/DL AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SHE SELF-TREATED WITH A CORRECTION BOLUS. SUBSEQUENTLY, SHE WAS ADMITTED IN THE HOSPITAL, WHERE SHE RECEIVED SOME UNSPECIFIED FLUIDS AND INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR FOUR DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR LESS THAN THREE DAYS. REPORTEDLY, HER BLOOD GLUCOSE HAD COME BACK TO THE TARGET. 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 8538554 ↗
• 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. REPORTEDLY, HER BLOOD GLUCOSE LEVEL WAS 1000 MG/DL AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SHE ATTEMPTED TO CHANGE THE SITE AND SELF-TREATED WITH CORRECTION BOLUSES WITH THE PUMP AND 10 UNITS OF MULTIPLE DAILY INJECTION. SHE ALSO GAVE 15 UNITS OF BOLUSES BY THE PUMP, ON THE DAY OF HER HOSPITALIZATION. SUBSEQUENTLY, SHE WAS HOSPITALIZED AND RECEIVED INSULIN AND INTRAVENOUS DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. SHE WAS ADMITTED FOR FOUR DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. 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 8538418 ↗
• InjuryApr 19, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AS A RESULT OF BENT CANNULA. THE PATIENT WENT INTO THE EMERGENCY AND STAYED THERE FOR LESS THAN 1 DAY. THE BLOOD GLUCOSE LEVEL WHEN THE PATIENT ARRIVED AT THE EMERGENCY, WAS 1230 MG/DL AND 700 MG/DL WHEN SHE LEFT THE EMERGENCY. SHE HAD VERY LARGE KETONE LEVELS AND THE HEALTH CARE PROFESSIONAL IDENTIFIED THE KETONE LEVEL AS LIFE THREATENING. THE INFUSION HAD BEEN IN USE FOR 1 DAY. SHE WAS TREATED WITH IV FLUIDS AND INSULIN AND THIS RESOLVED THE ISSUE. SHE WAS HOSPITALIZED FOR 4 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 8530499 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED BY THE PATIENT'S MOTHER THAT HER DAUGHTER'S INFUSION SET'S CANNULA WAS KINKED, AND WHICH LED TO ELEVATED BLOOD GLUCOSE LEVELS. IT WAS TREATED WITH CORRECTION BOLUS AND MULTIPLE DAILY INJECTIONS. REPORTEDLY, THE PATIENT WAS ADMITTED AS HER BLOOD GLUCOSE WAS 500 MG/DL AND SHE HAD DIABETIC KETOACIDOSIS. THE MOTHER REPORTED THAT REPORTED, AT THE HOSPITAL AFTER HER SITE WAS REMOVED, THEY NOTICED THE SITE WAS KINKED. DURING HOSPITALIZATION SHE RECEIVED, INTRAVENOUS INSULIN DRIP WHICH RESOLVED THE ISSUE AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. SHE WAS DISCHARGED FROM THE HOSPITAL APPROXIMATELY TWO DAYS LATER. THE INFUSION SET WAS USED FOR ONE 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 8517510 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED ISSUED WITH THE INFUSION SET IN THE FORM OF BENT CANNULA, WHICH WAS NOTICED AFTER REMOVING IT. PRIOR TO HOSPITALIZATION, SHE SELF-TREATED WITH A BOLUS FROM THE PUMP. REPORTEDLY, THE BLOOD GLUCOSE WAS 1004 MG/DL AND SHE EXPERIENCED DIABETIC KETOACIDOSIS, WHICH LED TO HOSPITALIZATION. SHE RECEIVED INTRAVENOUS INSULIN DRIP WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR ONE DAY. SHE WAS ADMITTED FOR TWO DAYS. SHE STATED THAT SHE WAS NOW ON CARDIAC MEDICINE AFTER THE HOSPITALIZATION. 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 8517433 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED ISSUED WITH THE INFUSION SET IN THE FORM OF BENT CANNULA, WHICH WAS NOTICED AT THE HOSPITAL. REPORTEDLY, THE BLOOD GLUCOSE WAS 1100 MG/DL AND HE EXPERIENCED DIABETIC KETOACIDOSIS, UPON ARRIVAL IN THE EMERGENCY ROOM. PRIOR TO HOSPITALIZATION, HE SELF-TREATED WITH A BOLUS FROM THE PUMP AND CONFIRMED THAT HE SUCCESSFULLY DELIVERED ALL BOLUSES. IN THE EMERGENCY ROOM, THE PATIENT STAYED FOR A FEW HOURS AND WAS PUT UNDER WARM BLANKETS AND RECEIVED INTRAVENOUS INSULIN DRIP AND FLUIDS. THE PATIENT FELT A BIT BETTER AND HAD A LESS URGE TO VOMIT, WHEN LEFT THE EMERGENCY ROOM. SUBSEQUENTLY HE WAS HOSPITALIZED, WHERE HE RECEIVED ELECTROLYTES, INTRAVENOUS INSULIN DRIP, AND RESUMED INSULIN FROM THE PUMP WHICH RESOLVED THE ISSUE. THE BLOOD GLUCOSE WAS 395 MG/DL THE NIGHT BEFORE THIS REPORT AND 267 MG/DL AT THE TIME OF THIS REPORT. THE INFUSION SET WAS USED FOR ONE AND A HALF DAY. HE WAS ADMITTED 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, TH

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517416 ↗
• InjuryApr 16, 2019Device Handling Problem; Device Handling Problem

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A COMPROMISED INFUSION SITE. REPORTEDLY, THE BLOOD GLUCOSE LEVEL WAS 380 MG/DL, WHICH WAS SELF-TREATED WITH A CORRECTION USING MULTIPLE DAILY INJECTION. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED AND RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE PATIENT WAS ADMITTED FOR THREE DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517056 ↗
• MalfunctionApr 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET RIPPED OUT EARLY THIS MORNING WHILE SHE WAS ASLEEP. REPORTEDLY, THE BLOOD GLUCOSE WAS 600MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8468764 ↗
• MalfunctionApr 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT, THE INFUSION SET'S TUBING CAME OFF THE CONNECTER NEEDLE. REPORTEDLY, PRIOR TO ATTEMPTING INSERTION INTO BODY THERE WAS NO DAMAGE/IRREGULARITIES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468650 ↗
• MalfunctionMar 31, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT WAS AT SCHOOL AND HER SITE BECAME DETACHED. PATIENT'S BLOOD GLUCOSE LEVEL WAS 181 MG/DL AT THE TIME OF EVENT. THE PATIENT WAS ABLE TO REPLACE SITE AND TUBING AND WAS ABLE TO RESUME DELIVERY. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467967 ↗
• MalfunctionMar 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD A TUBING ISSUE AS IT WAS CRACKED/BROKEN. THE TUBING CAME APART FROM THE INFUSION SET PRIOR TO USE. IN THE INVESTIGATION IT WAS FOUND THAT THE GLUE WAS MISSING FROM THE TUBING CONNECTOR (GLUE WAS MISPLACED ON THE TUBING CONNECTOR). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467966 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S SITE DETACHED FROM HIS BODY WHILE HE WAS SLEEPING. THE BLOOD GLUCOSE WAS REPORTED AS 358 MG/DL AND THE PATIENT SELF-TREATED WITH MANUAL CORRECTION INJECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8462879 ↗
• MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT ABOUT A MONTH BEFORE THIS REPORT, ONE OF HER INFUSION SETS BROKE COMPLETELY AT THE SITE. THE TUBING CAME OFF THE CLIP AT THE SITE. AT THE TIME OF THIS EVENT, HER BLOOD GLUCOSE LEVEL WAS CLOSE TO BEING OVER 500 MG/DL. IN THE MORNING OF THIS REPORT, WHEN SHE WOKE UP, SHE NOTICED THAT THE TUBING HAD COMPLETELY SNAPPED OFF THE CLIP AT THE SITE. AT THE TIME OF THE EVENT, HER BLOOD GLUCOSE LEVEL WAS AT 462 MG/DL. BOTH TIMES, SHE SELF-TREATED IT WITH MULTIPLE DOSE INJECTION AND WAS ABLE TO CHANGE HER SITE TO GET HER BLOOD GLUCOSE LEVEL DOWN WITHIN TARGET RANGE. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8447409 ↗