inset™ 100-181-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 05705244006881), received between Jan 2, 2019 and Apr 23, 2019 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (8 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 16 most recent of 16 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 A BENT CANNULA ISSUE DUE TO WHICH THE PATIENT EXPERIENCED HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS, WHICH THE PATIENT SELF-TREATED WITH CORRECTION BOLUSES. THE PATIENT WENT TO THE EMERGENCY ROOM AND UPON ARRIVAL, PATIENT'S BLOOD GLUCOSE LEVEL WAS IN 300S MG/DL. THE PUMP WAS TAKEN OFF, AND THE PATIENT WAS GIVEN INSULIN VIA INTRAVENOUS ROUTE AND SALINE. THE DOCTOR DEEMED THIS A DANGEROUS EVENT. WHEN THE PATIENT LEFT THE EMERGENCY ROOM, BLOOD GLUCOSE LEVEL WAS IN 200S MG/DL AND THE PATIENT WAS STILL NOT FEELING WELL. SUBSEQUENTLY, THE PATIENT WAS ADMITTED TO THE HOSPITAL WHERE THE PATIENT RECEIVED INSULIN AND SALINE VIA INTRAVENOUS ROUTE, WHICH RESOLVED THE ISSUE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET HAD BEEN IN USE FOR THREE DAYS. THE PATIENT STAYED IN THE HOSPITAL 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8539123 ↗
• 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. REPORTEDLY THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 846 MG/DL AND HAD EXPERIENCED DIABETIC KETOACIDOSIS 1+ LEVELS. THE PATIENT SELF-TREATED WITH THE BOLUS. SUBSEQUENTLY, THE PATIENT RECEIVED INSULIN DRIP AND DEXTROSE 5% IN NORMAL SALINE AS CORRECTIVE TREATMENT. THE ISSUE WAS RESOLVED, AS THE BLOOD GLUCOSE LEVEL NOW WAS REPORTED TO BE 190 MG/DL. THE PATIENT WAS ADMITTED 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 8538449 ↗
• InjuryApr 22, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD BENT CANNULA ISSUE. REPORTEDLY, THE BLOOD GLUCOSE LEVELS WERE OVER 600 MG/DL AND HAD EXPERIENCED DIABETIC KETOACIDOSIS, WHICH WAS SELF-TREATED WITH A CORRECTION BOLUS. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED, AND IT WAS NOTICED THAT CANNULA WAS BENT. THE PATIENT RECEIVED INTRAVENOUS INSULIN AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR THREE DAYS. THE PATIENT WAS ADMITTED FOR THREE DAYS AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. MOREOVER, IT WAS ALSO REPORTED THAT THE PATIENT WENT TO THE HOSPITAL FOR THE SAME REASON BUT WAS DISCHARGED THE NEXT DAY AFTER THE TREATMENT. 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 8538406 ↗
• 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 WHICH LED TO ELEVATED BLOOD GLUCOSE LEVELS. HE SELF-TREATED IT WITH BOLUS AND MANUAL INJECTIONS. REPORTEDLY, THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AS HIS BLOOD GLUCOSE WAS OVER 500 MG/DL AND HAD KETONES. THE HEALTH CARE PROFESSIONAL ASSESSED THE KETONE LEVEL AS DANGEROUS/LIFE THREATENING. IN THE EMERGENCY ROOM, HE STAYED FOR A COUPLE OF HOURS AND HE RECEIVED INTRAVENOUS FLUIDS AND INSULIN. HIS BLOOD GLUCOSE REMAINED HIGH AND HE WAS STILL HAD DIABETIC KETOACIDOSIS, THUS HE WAS ADMITTED TO THE HOSPITAL LATER IN THE DAY. DURING HOSPITALIZATION HE RECEIVED, INTRAVENOUS FLUIDS AND INSULIN WHICH RESOLVED THE ISSUE AND THERE WAS NO PERMANENT DAMAGE TO THE PATIENT. THE INFUSION SET WAS USED FOR ABOUT 48 HOURS AT THE TIME OF 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 REMO

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517506 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT HAD EXPERIENCED AN ISSUE WHERE SHE WAS TAKEN TO THE HOSPITAL DUE TO BEING UNRESPONSIVE IN DIABETIC KETOACIDOSIS. WHEN THEY ARRIVED AT THE HOSPITAL THE MEDICAL TEAM DISCOVERED THAT SHE HAD A BENT CANNULA AND WAS TAKEN OFF THE PUMP TO BE TREATED. REPORTEDLY, THE BLOOD GLUCOSE WAS NEAR 600 MG/DL. THE PATIENT RECEIVED SOME UNSPECIFIED FLUIDS AND INSULIN WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS USED FOR LESS THAN ONE DAY. THE PATIENT WAS ADMITTED FOR FIVE 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 8517471 ↗
• InjuryApr 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT HAD ISSUE WITH HER INFUSION SET AND HAD HIGH BLOOD GLUCOSE LEVELS. SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM AND HER BLOOD GLUCOSE WAS ABOVE 800 MG/DL AND HER KETONES WERE HIGH. HER HEALTH CARE PROFESSIONAL NOTICED THAT SHE HAD A KINK IN HER LONG TUBING. SHE STAYED IN THE EMERGENCY FOR TWO HOURS AND HER BLOOD GLUCOSE WAS ABOVE 700 MG/DL WHEN SHE WAS HOSPITALIZED AND WAS IN THE INTENSIVE CARE UNIT WHERE SHE RECEIVED FLUIDS VIA A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE TO HER HEART AND INSULIN VIA A HOSPITAL PUMP WHICH RESOLVED THIS ISSUE. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS. THE PATIENT'S KIDNEYS WERE 'FAILING' AFTER THIS INCIDENT, BUT SHE SAID SHE WAS BETTER OFF SINCE. THE INFUSION SET WAS USED FOR LESS THAN ONE DAY. THE PATIENT REPORTED TO RESOLVE THE ISSUE SHE KEPT GIVING HERSELF CORRECTIVE BOLUSES BEFORE GOING TO THE EMERGENCY ROOM. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8513210 ↗
• 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. THE PATIENT REPORTED THAT HIS INFUSION SET'S TUBING BROKE OFF AT THE SITE YESTERDAY. REPORTEDLY, THE BLOOD GLUCOSE LEVEL WAS 244 MG/DL AT TIME OF INCIDENT WHICH HE TREATED WITH MULTIPLE DAILY INJECTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468129 ↗
• 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. THE PATIENT REPORTED THAT HER INFUSION SET'S TUBING BROKE OFF FROM THE BASE OF THE CONNECTER PIECE THAT WAS CLIPPED INTO HER SITE, WHICH CAUSED HIGH BLOOD GLUCOSE LEVEL, IN THE MIDDLE OF THE NIGHT. THE PATIENT WENT TO THE EMERGENCY ROOM, AS SHE EXPERIENCED DIABETES KETOACIDOSIS SYMPTOMS ALONG WITH HIGH BLOOD GLUCOSE LEVEL (900 MG/DL). SHE WAS TREATED WITH INSULIN DRIP AND FLUIDS FEW HOURS IN EMERGENCY ROOM, BUT SHE FELT UNSTABLE AND WAS SUBSEQUENTLY ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT RECEIVED INSULIN DRIP AND INTRAVENOUS FLUIDS AS CORRECTIVE TREATMENT WHICH RESOLVED THE ISSUE. THE INFUSION SET WAS IN USE FOR A DAY AND A HALF. THE PATIENT WAS HOSPITALIZED FOR FEW DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8467995 ↗
• 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. THE PATIENT REPORTED THAT THE TUBING BROKE OFF FROM THE CONNECTOR PIECE OF HER INFUSION SET WHICH CAUSED HIGH BLOOD GLUCOSE LEVEL OF 524 MG/DL. REPORTEDLY, SHE CHANGED OUT THE SITE AND SELF-TREATED WITH A CORRECTION BOLUS WITH THE PUMP. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8467994 ↗
• MalfunctionMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET FELL APART UPON OPENING. UPON 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 8463672 ↗
• MalfunctionMar 29, 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 TUBING BROKE APPROXIMATELY 4 INCHES FROM THE LUER-LOCK CONNECTION. THE PATIENT ALSO STATED THAT THE TUBING APPEARED TO HAVE BEEN CUT. THE PATIENT HAD HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE OVER 240 MG/DL, WHICH WAS TREATED WITH A MANUAL INJECTION OF INSULIN. THE PATIENT ALSO HAD HIGH LEVEL OF KETONES. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE PATIENT WAS ABLE TO SUCCESSFULLY APPLY A NEW INFUSION SET TO THE CUSTOMER AND RESUME INSULIN ON THE PUMP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8463046 ↗
• MalfunctionMar 15, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED THAT ON A FEW INSTANCES (INCLUDING TODAY) SHE DID NOT SAW DROPS COME OUT OF THE TUBING, SO SHE HAD TO USE A NEW INFUSION SET. SHE ALSO SAID A COUPLE OF TIME, THE TUBING BECAME DETACHED FROM THE CANNULA HOUSING DURING THE LOAD PROCESS AND SHE HAD TO USE NEW SETS. REPORTEDLY, AT THE TIME OF THIS EVENT, SHE SAW INSULIN MIGRATE THROUGH THE LINE DURING THE FILL TUBING STEP, BUT NO DROPS EVER CAME OUT AND SHE ALSO SAW SOME AIR BUBBLES. THE BLOOD GLUCOSE WAS 136 MG/DL AT THE TIME OF THIS EVENT. THE PATIENT DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. MOREOVER, THE PATIENT DID NOT DO THE AIR REMOVAL STEP AS PER PROTOCOL WHEN PREPARING THE CARTRIDGE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8423578 ↗
• InjuryJan 31, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED BENT CANNULA ISSUES THAT RESULTED IN AN INCREASED BLOOD GLUCOSE LEVEL OF 560 MG/DL. THE PATIENT WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS DUE TO WHICH THE PATIENT EXPERIENCED NAUSEA, VOMITING AND SYMPTOMS OF DEHYDRATION INCLUDING DIZZINESS AND LIGHTHEADEDNESS. THE PATIENT WAS HOSPITALIZED AND RECEIVED TREATMENT OF INTRAVENOUS FLUIDS, INSULIN VIA INTRAVENOUS ROUTE, AND MEDICATION FOR NAUSEA AS WELL. THERE WAS NO DAMAGE/IRREGULARITIES PRESENT PRIOR TO USE. THE PATIENT'S MOTHER WAS UNSURE OF THE INSERTION TECHNIQUE USED AND THE NUMBER OF DAYS THE INFUSION HAD BEEN IN USE. THE PATIENT WAS HOSPITALIZED FOR 3 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 8291932 ↗
• InjuryJan 21, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE FOR THREE DAYS AND LEVELS WERE NOT COMING DOWN. SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM (ER) WITH BLOOD GLUCOSE LEVEL OVER 600 MG/DL WITH KETONES AS WELL AND IN THE ER MULTIPLE DAILY INJECTIONS WERE GIVEN ONCE ER AND THEN ADMITTED TO HOSPITAL. REPORTEDLY, SHE EVEN HAD MYOCARDIAL INFARCTION AS WELL. WHEN SHE LEFT ER, THE BLOOD GLUCOSE LEVEL WAS COMING DOWN (IN 300S MG/DL) AND IN CONTROL. REPORTEDLY, THE PATIENT HAD USED SEVERAL INFUSIONS SET. SHE WAS HOSPITALIZED FOR THREE DAYS AND HAD ANEURYSM AS WELL BUT WAS NOT FROM DIABETES 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 8263457 ↗
• InjuryJan 7, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE (528 MG/DL) LEVEL AT HOME AT HOME AND SHE GAVE HERSELF A MANUAL INJECTION OF INSULIN PRIOR TO GOING TO HOSPITAL AND STATED THAT SHE WENT TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE (333 MG/DL) AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE PATIENT'S METABOLIC PROFILE WAS RESET, FLUIDS AND NEW INFUSION SET WAS GIVEN TO THE PATIENT AS A CORRECTIVE TREATMENT IN THE HOSPITAL. THE PATIENT RESUMED THE PUMP THERAPY IN HOSPITAL AFTER STABILIZATION. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS. THE PATIENT WAS NOT FOLLOWING THE IFU IN RELATION TO NOT SECURING THE TAPE DURING INSERTION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8221216 ↗
• InjuryJan 2, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED A KINKED CANNULA ON TWO SEPARATE OCCASIONS, ONCE ABOUT 5 WEEKS AGO AND ONCE ABOUT 1 WEEK AGO BEFORE THIS REPORT. WHEN THE EVENT OCCURRED FOR THE FIRST TIME, THE BLOOD GLUCOSE LEVEL AT THE TIME OF EVENT WAS 525 MG/DL. SHE EVEN HAD ELEVATED KETONE LEVEL BUT DID NOT RECALL THE LEVEL. AS A CORRECTIVE TREATMENT, SHE RECEIVED BOLUS VIA PUMP AND WENT TO EMERGENCY ROOM (ER). THE ER STAFF DETERMINED CANNULA WAS STILL IN HER BODY AND IT WAS REMOVED. SHE WAS GIVEN INTRAVENOUS INSULIN DRIP IN THE ER. WHEN SHE LEFT ER, THE BLOOD GLUCOSE LEVEL WAS 366 MG/DL. THOUGH THE BLOOD GLUCOSE LEVEL WAS COMING DOWN HOWEVER, SHE WAS STILL NOT FEELING WELL. SHE DID NOT NOTICE ANY DAMAGE WHEN THE PACKAGE WAS FIRST OPENED. THE INFUSION SET HAD BEEN USED FOR 1 DAY. THE PATIENT WAS IN HOSPITAL FOR 3 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 AVAILABL

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8211216 ↗