Quick-set® Paradigm® MMT-397600Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 05705244006393), received between Jan 30, 2019 and Aug 18, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2026Use of Incorrect Control/Treatment Settings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50295722 ↗
• MalfunctionJun 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA ON (B)(6) 2022, IT WAS REPORTED THAT THE TWO INFUSION SETS DETACHED. FURTHER, THERE WAS NO STRESS OR PULL ON THE TUBING. REPORTEDLY, THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742014 ↗
• MalfunctionJan 20, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT THE PLASTIC PIECE DISLODGED FROM THE TAPE AND THE WHOLE OF THE CANNULA DETACHED. ON (B)(6) 2022, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS REPORTED AS 18.3 MMOL/L. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN, AND THE PUMP WAS LOCATED ON THE WAIST BAND. MOREOVER, THE INFUSION HAD BEEN USED FOR A DAY BEFORE. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, THE MOTHER WAS IN PROCESS OF CHANGING THE INFUSION SET AS THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13305872 ↗
• MalfunctionMay 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, IT WAS REPORTED THAT WHEN THE PATIENT WAS ABOUT TO PUT IN (INSERT) AN INFUSION SET ONE MONTH AGO (APPROXIMATELY), THE INFUSION SET'S TUBING PULLED OUT AT THE QUICK RELEASE DURING THE MIDDLE OF THE NIGHT WHILE HE WAS SLEEPING, AND HE HAD TO DO A FULL SET CHANGE THE NEXT MORNING, AS HE HAD HIGH BLOOD GLUCOSE LEVELS. REPORTEDLY, HE DID NOT REMEMBER THE BLOOD GLUCOSE LEVEL BUT STATED THAT IT WAS IN THE HIGH TEENS. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS ON HIS WAIST BAND ON THE SAME SIDE IN RELATION TO THE INFUSION SET. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY (APPROXIMATELY). REPORTEDLY, THE INFUSIONS WERE STORED AT ROOM TEMPERATURE ON A SHELF. THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. UPON INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11789302 ↗
• MalfunctionMar 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME APART AT THE RESERVOIR/ SITE, WHILE THE PATIENT WAS WALKING/ SITTING DOWN. REPORTEDLY, THE SITES GOT BROKEN AND THE TUBING POPPED OUT OF THE SITE END. THE SITE LOCATION WAS THE PATIENT'S RIGHT UPPER BUTTOCK AND THE PUMP WAS ON THE SAME SIDE. THE INFUSION HAD BEEN USED FOR THE FIRST DAY. MOREOVER, THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11460998 ↗
• MalfunctionApr 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, THE PATIENT REPORTED THAT OVER THE WEEKEND, THE INFUSION SET'S TUBING DETACHED AT THE CONNECTOR WHILE HE WAS SLEEPING. FURTHER, THE SITE LOCATION WAS PATIENT'S BACK AND THE PUMP WAS LOCATED ON THE FRONT SIDE IN RELATION TO THE SITE. MOREOVER, THE INFUSION HAD BEEN IN USE FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9961283 ↗
• MalfunctionMar 27, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT WHILE THE PATIENT WAS CHANGING THE INFUSION SET, THE TUBING DETACHED AT THE SITE. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S BELLY AND THE PUMP WAS AT RIGHT SIDE. MOREOVER, THE INFUSION HAD NOT BEEN USED. THE INFUSIONS WERE STORED IN PROPER CONDITION. REPORTEDLY, THE PATIENT WAS UNSURE WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9887259 ↗
• MalfunctionJan 2, 2020Crack; Crack

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT HER THREE INFUSION SETS BROKE AT THE QUICK RELEASE, 3 TIMES IN 3 CONSECUTIVE DATES WHILE SHE WAS SLEEPING. FURTHER, LEAKAGE WAS OBSERVED BECAUSE OF THE BREAKAGE. ALL THE INFUSION SETS WERE FROM THE SAME BOX. ON (B)(6) 2019, SHE HAD HIGH BLOOD GLUCOSE LEVEL OF 27.9 MMOL/L (AT THE TIME OF THE INCIDENT). SUBSEQUENTLY, ON THE SAME DAY AT 6 AM, SHE WAS TAKEN TO EMERGENCY ROOM AS SHE WAS NOT FEELING WELL AT ALL, WAS DIZZY AND DISORIENTED, HAD NAUSEA AND VOMITING, THUS WAS HOSPITALIZED FOR ONE DAY. DURING HOSPITALIZATION, SHE RECEIVED MANUAL INJECTIONS. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 7.1 MMOL/L AND SHE WAS USING A DIFFERENT INFUSION SET FROM A DIFFERENT BOX. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9537484 ↗
• MalfunctionSep 2, 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 INFUSION SET'S TUBING DETACHED CLOSE TO THE SITE AND HER BLOOD GLUCOSE LEVEL WAS 18 MMOL/L. THE SITE LOCATION WAS AT PATIENT'S RIGHT ABDOMEN AND THE PUMP WAS IN HER POCKET. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953479 ↗
• MalfunctionJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE INFUSION SET'S TUBING CAME APART CLOSE TO THE SITE. THE INFUSION SET HAD NOT BEEN USED AT THE TIME OF DETACHMENT. THE SITE LOCATION WAS PATIENT'S HIP AND THE PUMP WAS IN THE PATIENT'S POCKET. THE INFUSIONS WERE NOT STORED OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726305 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT ABOUT 2-3 WEEKS BEFORE THIS REPORT, HER BLOOD GLUCOSE LEVEL WAS AT 40 MMOL/L AND SHE EXPERIENCED DIABETIC KETOACIDOSIS. SUBSEQUENTLY, SHE WAS HOSPITALIZED WHERE SHE WAS PUT ON INSULIN INFUSION AND INJECTIONS. SHE WAS CONNECTED TO HER PUMP THE WHOLE TIME UNTIL THE VERY LAST DAY THEY DISCONNECTED HER FROM THE PUMP. WHEN THEY REMOVED THE CANNULA, IT WAS FOUND TO BE BENT. THEY INSERTED A BRAND-NEW INFUSION SET ON A NEW SITE AND IT WORKED FOR A COUPLE OF DAYS. SINCE SHE HAD CHANGED SITE HER BLOOD GLUCOSE LEVEL HAD BEEN GOING TOO LOW. SHE HAD TOO MUCH SCAR TISSUE AND HARDENED TISSUE ON HER ABDOMEN. 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 FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8539242 ↗
• InjuryApr 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT SHE HAD HIGH BLOOD GLUCOSE LEVEL WHEN SHE CHANGED HER SET. HER BLOOD GLUCOSE LEVEL STARTED GOING DOWN AND SHE WENT TO SLEEP. SHE WOKE UP WITH BLOOD GLUCOSE LEVEL AT 19 MMOL/L. THE PATIENT TOOK A BOLUS AGAIN AND WENT TO WORK THE NEXT DAY BUT HER BLOOD GLUCOSE LEVEL NEVER CAME DOWN. THEREFORE, SHE DECIDED TO CHECK HERSELF IN THE EMERGENCY ROOM AS SHE STARTED HAVING CHEST PAIN. THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 25 MMOL/L AT THE TIME OF INCIDENT AND ALSO FELT SLIGHTLY NAUSEOUS. SUBSEQUENTLY, THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT DUE TO DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVEL UPON ADMISSION WAS 18.4 MMOL/L. UPON REMOVAL OF THE INFUSION SET, THE CANNULA WAS FOUND TO BE COMPLETELY BENT. THE PATIENT HAD STRETCH MARKS ON HER ABDOMEN. THE PATIENT HAD BEEN IN THE HOSPITAL FOR TWO DAYS AND WAS STILL THERE WITH BLOOD GLUCOSE LEVEL AT 6.8 MMOL/L, AT THE TIME OF THIS REPORT. 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. FURTHER

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8538543 ↗
• MalfunctionApr 9, 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 ISSUES WITH TWO INFUSION SETS. SHE STATED THAT SOMETIME AFTER INSERTION, SHE NOTICED THAT THE TUBING WAS DETACHED OR UNGLUED FROM THE PART THAT WAS NOT ATTACHED TO HER BODY. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494668 ↗
• MalfunctionApr 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED ANOTHER DETACHMENT AND HAD ELEVATED BLOOD GLUCOSE BECAUSE THEY JUST HAD DINNER. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468180 ↗
• MalfunctionMar 30, 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 SHE WAS PLAYING SOFTBALL AND WAS RUNNING FROM HOME TO FIRST BASE WHEN TUBING GOT DETACHED FROM THE QUICK RELEASE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467936 ↗
• MalfunctionMar 28, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT ON THE DAY OF THIS REPORT, THE INFUSION SET'S TUBING SEPARATED AT THE INFUSION SET ATTACHMENT. THE ISSUE OCCURRED ON THE FOURTH DAY OF USE. IT HAD HAPPENED AROUND TWO WEEKS AGO ALSO. IT CAME TO NOTICE AFTER HE WOKE UP FROM SLEEP WITH HIGH BLOOD GLUCOSE LEVEL, WHICH HE TREATED RIGHT AWAY. THE SITE WAS UPPER BUTTOCKS AND THE PUMP WAS ON THE SAME SIDE ATTACHED WITH THE BELT CLIPS. THE PATIENT DID NOT SEEM TO HAVE STRESSED OR PULLED THE TUBING AND THE PUMP WAS NOT DROPPED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8458887 ↗
• MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED FROM THE PLASTIC PART ATTACHED TO THE ADHESIVE. REPORTEDLY, THE ENTIRE PLASTIC PART (WITH NEEDLE GUARD/CANNULA) CAME OUT. MOREOVER, THE PATIENT GOT INFECTED BY BACTERIA AND THE PART OF BODY WHERE THE INFUSION SET WAS INSERTED WAS INFECTED (REDNESS, BUMP AND HARD). THE SITE WAS STOMACH AND THE PUMP WAS ALWAYS CLIPPED ON HIS POCKET. THE INFUSION HAD BEEN IN USE FOR EVERY 2-3 DAYS. THE INFUSIONS WERE STORED IN A DRY PLACE IN THE CUPBOARD OF HIS KITCHEN. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Unspecified Infection

  MAUDE report 8447328 ↗
• MalfunctionMar 25, 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 WHILE SLEEPING THE INFUSION SET'S TUBING CAME APART FROM THE CONNECTOR. THE SITE WAS AT THE LEFT SIDE OF STOMACH AND THE PUMP WAS IN THE POCKET, CLIPPED TO THE SHIRT. THE INFUSIONS HAD BEEN IN USE FOR 12 HOURS. THE INFUSIONS WERE STORED IN A DRY CLOSET. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8447142 ↗
• InjuryFeb 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S FATHER REPORTED THAT THE CANNULA FROM AN INFUSION SET STAYED IN HIS DAUGHTER'S BODY AND THE INFUSION SET WAS INSERTED ABOUT 3-4 WEEKS AGO BEFORE THIS REPORT. SHE INDICATED THAT THE SITE LOOKED INFECTED AND TWO WEEKS BEFORE THIS REPORT, SHE WAS PRESCRIBED ANTIBIOTICS BY THE DOCTOR. BUT, THE INFECTION REAPPEARED AGAIN, AND THE DOCTOR PERFORMED SURGERY UNDER LOCAL ANESTHETIC. THE AREA WAS CLEANED, AND A PIECE OF PLASTIC WAS REMOVED FROM HER BODY THAT WAS CURLED UP IN A BALL. WHEN THE PIECE OF PLASTIC WAS REMOVED IT SPRINGED BACK STRAIGHT AND IT WAS THE CANNULA OF THE INFUSION SET THAT WAS STUCK INSIDE THE SKIN. THE DOCTOR GAVE HER NEW ANTIBIOTICS. THE SAMPLES OF DISCHARGE FROM THE WOUND WERE SENT TO A LAB. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Tissue Damage

  MAUDE report 8324667 ↗
• MalfunctionFeb 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT HE WOKE UP BECAUSE HE FELT THAT HIS BLOOD GLUCOSE LEVEL WAS GOING UP AND IT WAS 17.5 MMOL/L. REPORTEDLY, THE INFUSION SET TUBING HAD DETACHED FROM THE SITE WHILE THE PATIENT WAS SLEEPING IN THE NIGHT. THE SITE LOCATION WAS PATIENT'S LEFT BUTTOCK. THE PUMP WAS HOOKED TO THE PATIENT'S PAJAMA IN THE MIDDLE OF THE ABDOMEN. THE INFUSION WAS USED FOR MORE THAN 2 DAYS. THE INFUSIONS WERE KEPT AT ROOM TEMPERATURE IN THE KITCHEN. THE PATIENT WAS UNCERTAIN WHETHER THERE WAS ANY STRESS OR PULL ON THE TUBING. THE PUMP WAS DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. HE STATED THAT THIS HAD HAPPENED TO HIM BEFORE IN THE PAST AND WANTED TO KNOW IF THIS ISSUE HAPPENS OFTEN WITH THE DEVICE. FURTHERMORE, HE CHANGED THE SITE, INFUSION SET AND RESERVOIR AND DID CORRECTION WITH PUMP WHICH BROUGHT HIS BLOOD GLUCOSE TO 3.7 MMOL/L RIGHT BEFORE LUNCH. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8324646 ↗
• InjuryJan 30, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT FACED BENT CANNULA ISSUES TWICE ON THE SAME DAY THAT RESULTED IN HIGH BLOOD GLUCOSE LEVEL OF 44 MMOL/L AND NAUSEA, WHICH WAS TREATED WITH SYRINGE AND INSULIN. REPORTEDLY, SHE WENT TO THE DOCTOR WHO RECOMMENDED HER TO GO TO EMERGENCY. SHE WAS THEN ADMITTED TO THE HOSPITAL BECAUSE OF HIGH BLOOD GLUCOSE AND KETONES LEVEL. SHE RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT AND WAS HOSPITALIZED FOR 2 DAYS. AT THE TIME OF THIS REPORT, HER BLOOD GLUCOSE WAS 6.7 MMOL/L. 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 8287929 ↗