Minimed™ Mio™ MMT-943A600Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05705244020337), received between Mar 5, 2021 and Feb 11, 2026 — classified as 12 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Material Twisted/Bent

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR ONE DAY. THE BLOOD GLUCOSE LEVEL WAS 31MMOL/L. THE PATIENT WAS HOSPITALIZED DUE TO HYPERGLYCEMIA AND THE DURATION OF HOSPITALIZATION IS SEVEN HOURS . NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 24319653 ↗
• InjuryDec 21, 2023Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2023, THE PATIENT'S MOTHER REPORTED THAT THE PUMP WAS HAVING MULTIPLE INSULIN FLOW BLOCKED ALARMS WITH MULTIPLE INCIDENTS DURING THERAPY OVER PAST WEEKS. FURTHER, FOR ONE SUCH INCIDENT, THE PATIENT WENT TO EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 18370542 ↗
• InjuryJun 1, 2023Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6)2023, THE PATIENT'S MOTHER REPORTED THAT, LAST MONDAY ((B)(6)2023), HER CHILD EXPERIENCED VOMITING, WAS NOT FEELING WELL AND HAD HIGH BLOOD GLUCOSE LEVEL. THEREFORE, PATIENT'S MOTHER TRIED TO LOWER HER CHILD'S BLOOD GLUCOSE LEVEL. REPORTEDLY, ON (B)(6)2023, THE MOTHER CHANGED THE INFUSION SET WHEN SHE NOTICED A KINKED CANNULA. PREVIOUSLY, THERE WERE MULTIPLE INSULIN FLOW BLOCK. MOREOVER, THE INFUSION SET WAS USED FOR FIRST DAY AND THE ISSUE OCCURRED WHILE SLEEPING AT NIGHT. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 4.5 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 WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036820 ↗
• MalfunctionMay 29, 2023Detachment 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 PATIENT'S INFUSION SET'S TUBING DETACHED FROM THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S ABDOMEN. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE STORED NORMALLY. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. ACCORDING TO COMPLAINT INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 TUBING), THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR AS IT WAS NOT PROPERLY ASSEMBLED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017099 ↗
• InjuryFeb 9, 2023Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON 28-SEP-2021, THE PATIENT'S MOTHER REPORTED THAT HER SON WAS GETTING INSULIN FLOW BLOCK ALARM DURING BOLUS, AND HE GOT IT WITH PREVIOUS INFUSION SET AS WELL. THEREFORE, HIS BLOOD GLUCOSE LEVEL WAS 30 MMOL/L AT THE TIME OF THE EVENT. RECENTLY, SHE CHANGED EVERYTHING (2 MINUTES AGO) AND WAS STILL GETTING INSULIN FLOW BLOCK ALARM. MOREOVER, THE SITE LOCATION WAS PATIENT'S BUTTOCK. REPORTEDLY, THE PATIENT'S INFUSION SET CANNULA WAS BENT. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 12.8 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: Hyperglycemia

  MAUDE report 16330948 ↗
• MalfunctionNov 1, 2022Material Integrity Problem; Material Integrity Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER FACED AN INSULIN FLOW BLOCK WHICH STARTED LAST NIGHT. AT THE TIME OF THE EVENT, HER BLOOD GLUCOSE LEVEL WAS 25 MMOL/L, AND SHE CHANGED HER SITE THREE TIMES. THE PATIENT STATED THAT THE INSULIN EXITED FROM HER INFUSION SET TUBING, BUT THE TUBING WAS BENT. SHE PULLED THE TUBING AND THEN THE INSULIN CAME OUT. FURTHER, THE PATIENT CHANGED FULL INFUSION AND DID NOT EXPERIENCED ISSUES WITH FILLING TUBING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 15705835 ↗
• MalfunctionAug 17, 2022Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER CHILD FACED AN INSULIN FLOW BLOCKAGE DUE TO WHICH THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 23.6 MMOL/L. FIRST, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL ON (B)(6) 2022 AND CHANGED THE INFUSION SET ON THE SAME DAY PRIOR TO THE EVENT. THEREFORE, THEY TRIED TO TREAT IT WITH MANUAL INJECTION AS THEY WERE TRAVELLING AND TOOK IT OFF FOR 7 HOURS. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 18.7 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 15246824 ↗
• InjuryJun 30, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER HAD A BENT CANNULA LAST NIGHT. FURTHER, SHE INSERTED ANOTHER ONE AND THIS MORNING WHEN SHE WOKE UP, HER METER READING WAS HIGH AND WHEN THE CANNULA WAS REMOVED IT WAS BENT (90 DEGREE). REPORTEDLY, SHE INSERTED ANOTHER INFUSION SET (KEPT THE RESERVOIR) DID A BOLUS AND IT DELIVERED. SHE WENT TO DO A SECOND BOLUS AND GOT INSULIN FLOW BLOCK, HOWEVER, WHEN SHE REMOVED THE CANNULA, IT WAS STRAIGHT. THE SITE LOCATION WAS HER ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR LESS THAN A DAY. MOREOVER, SHE DID A MANUAL INJECTION. AT THE TIME OF THE INCIDENT, HER BLOOD GLUCOSE LEVEL WAS ABOVE 33.3 MMOL/L. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 18.1 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 14867461 ↗
• MalfunctionJun 2, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT FACED A BENT CANNULA THAT OCCURRED ON THE FIRST DAY OF USING THE INFUSION SET AND THIS ISSUE OCCURRED WITH FOUR INFUSION SETS. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE INFUSION SET HAD BEEN 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572000 ↗
• InjuryMay 23, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER SON HAD VOMITING DUE TO A BENT CANNULA. THIS ISSUE OCCURRED TWICE. THE FIRST INFUSION SET WAS LAST CHANGED ON (B)(6) 2022, BUT HIS BLOOD GLUCOSE LEVEL WENT HIGH APPROXIMATELY 20 MMOL/L, SO HIS MOTHER REMOVED AND CHANGED THE SET IN MIDDLE OF NIGHT. THE SITE LOCATION WAS HIS ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR LESS THAN 12 HOURS. CONSEQUENTLY, ON (B)(6) 2022 AT 5:00 PM, HE VISITED THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVELS AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, HE WAS ADMINISTERED INSULIN DRIP, SOME UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY AND INSULIN DRIP. HE WAS RELEASED AFTER 18 HOURS. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 4.2 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 14467925 ↗
• InjuryApr 27, 2022Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER SON HAD TO GO OVER SIX INFUSION SETS FROM SUNDAY ((B)(6) 2022) TILL TODAY DUE TO AN INSULIN FLOW BLOCKED. HIS BLOOD GLUCOSE LEVEL WAS 24 MMOL/L AT THE TIME OF INCIDENT. CURRENTLY, THE PATIENT WAS SLEEPING AS HE WAS NOT FEELING WELL, AND HIS MOTHER HAD TO GO TO PICK HIM UP FROM WORK AS HE WAS UNWELL. THE PATIENT EXPERIENCED DIARRHEA, HEADACHE, VOMITING AND HIS BLOOD GLUCOSE LEVEL WAS VERY ELEVATED. AT THE TIME OF THIS REPORT, HIS BLOOD GLUCOSE LEVEL WAS 8 MMOL/L AFTER TAKING FEW NEEDLES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 14217091 ↗
• InjuryApr 19, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). FOREIGN: (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVELS DUE TO A BENT CANNULA. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN. AT THE TIME OF THE INCIDENT THE PATIENT'S BLOOD GLUCOSE LEVEL WAS MORE THAN 33 MMOL/L AND THE INFUSION SET WAS CHANGED ON (B)(6) 2022 (IN THE MORNING). SUBSEQUENTLY, IN THE NIGHT OF (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF MORE THAN 33 MMOL/L AND KETONES, AND DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE PATIENT RECEIVED SOME UNSPECIFIED MEDICATION (DRUG NAME UNKNOWN) INTRAVENOUSLY AS CORRECTIVE TREATMENT. FURTHER, THE PATIENT WAS ADMITTED IN THE HOSPITAL OVERNIGHT. AT THE TIME OF THIS REPORT (CURRENTLY), THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 16.3 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 14139612 ↗
• MalfunctionApr 14, 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 INFUSION SET'S TUBING GOT DETACHED OUT OF THE BODY AND THIS ISSUE OCCURRED WHILE THE PATIENT WAS CHANGING THE INFUSION SET. REPORTEDLY, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14116631 ↗
• MalfunctionFeb 21, 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, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING DETACHED AT THE SITE WHILE INSERTION. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN, AND THE PUMP WAS ALSO LOCATED ON THE ABDOMEN. THE INFUSION SET HAD BEEN USED FOR LESS THAN 24 HOURS. 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 THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13567847 ↗
• InjuryFeb 4, 2022Infusion or Flow Problem; Infusion or Flow Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER HAD SOME ISSUES WITH HER PUMP. THEREFORE, HER PUMP KEPT ALARMING INSULIN FLOW BLOCKED. THEY CHANGED THE RESERVOIR AND TUBING, BUT THE ISSUE DID NOT RESOLVE. REPORTEDLY, THE ISSUE OCCURRED DURING BOLUS AND BASAL. ON THE DAY OF THIS REPORT ( (B)(6) 2022), THE PATIENT RECEIVED THE INSULIN FLOW BLOCKED ALARM AT 03:57 AM AND 04:15 AM. MOREOVER, ON (B)(6) 2022, SHE RECEIVED THE INSULIN FLOW BLOCKED ALARM AT 10:50 PM, THEREFORE, THEY CHANGED THE INFUSION SET AND RESERVOIR AT 10:57 PM AND HER BLOOD GLUCOSE LEVEL WAS 25 MMOL/L. FURTHER, THE PATIENT'S MOTHER REPORTED THAT THE EVENT WAS RESOLVED BY CHANGING THE COMPLETE SET. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 8.9 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 13448530 ↗
• InjuryFeb 1, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, IT WAS REPORTED THAT WHEN THE PATIENT WOKE UP, HE EXPERIENCED CHEST PAIN, HEADACHE, DISORIENTATION, BODY CRAMPED AND WAS THROWING UP (HIGH BLOOD GLUCOSE LEVEL). THE PATIENT STATED WHEN HE REMOVED THE INFUSION SET THE CANNULA WAS FOUND TO BE BENT AND HE FACED THIS ISSUE WITH FIVE INFUSION SETS WHEN HE REMOVED THEM. MOREOVER, THE INFUSION SET HAD BEEN USED SINCE (B)(6) 2022 AND THE SITE LOCATION WAS PATIENT'S BUTTOCK. RECENTLY, HIS HIGH BLOOD GLUCOSE LEVEL EVENT BEGAN ON (B)(6) 2022 AND SUBSEQUENTLY, AT 11:00 AM, HE WAS ADMITTED TO THE HOSPITAL DUE TO DIABETIC KETOACIDOSIS WITH BLOOD GLUCOSE LEVEL OF 26 MMOL/L. DURING HOSPITALIZATION, HE RECEIVED INSULIN VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. CURRENTLY, THE PATIENT WAS IN THE HOSPITAL AND HIS BLOOD GLUCOSE LEVEL WAS 13 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 13410802 ↗
• InjuryJan 24, 2022Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, THE PATIENT'S MOTHER REPORTED LEAKAGE AT THE PATIENT'S INFUSION SET SITE. THEREFORE, THEY DID NOT DISCARD THE RESERVOIR, BUT CHANGED THE SITE. HIS BLOOD GLUCOSE LEVEL WAS 10.9 MMOL/L AT THE TIME OF THE EVENT. REPORTEDLY, THE SITE LOCATION WAS PATIENT'S BUTTOCKS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13331896 ↗
• MalfunctionSep 2, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 22-AUG-2021, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING DETACHED CLOSE TO THE SITE WHILE THE PATIENT WAS SLEEPING, THE INSULIN WAS LEAKING AND THE SAME ISSUE OCCURRED ON (B)(6) 2021 AS WELL. THEREFORE, THE PATIENT EXPERIENCED NAUSEA, THIRST, DIZZINESS, HEADACHE, FATIGUE, LACK OF APPETITE, DIFFICULTY IN WAKING UP AND HAD KETONE LEVELS. THE SITE LOCATION WAS PATIENT'S ABDOMEN, AND THE PUMP WAS IN HER POCKET. MOREOVER, THE INFUSION HAD BEEN USED 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. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 23.3 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 12411868 ↗
• InjuryAug 24, 2021Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT FACED A BENT CANNULA WITH FOUR OF HER INFUSION SETS AND DUE TO WHICH SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL (YESTERDAY, AT 04:30 PM), HEADACHE, VOMITING, WAS FEELING SICK AND WEAK. THEREFORE, SHE TRIED TO TREAT IT WITH MANUAL INJECTION BUT YESTERDAY ((B)(6) 2021), AT 06:00 PM, SHE ENDED UP IN THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE LEVEL OF 26.1 MMOL/L AND SHE WAS TESTED FOR DIABETIC KETOACIDOSIS AS SHE HAD HIGH KETONE LEVELS. REPORTEDLY, SHE JUST CHANGED THE INFUSION SET IN THE MORNING, IT WAS USED FOR 8 HOURS. AFTER STAYING FOR SIX HOURS IN EMERGENCY ROOM, THE PATIENT WAS RELEASED. SHE GOT BACK WITH BLOOD GLUCOSE LEVEL OF 14 MMOL/L AND WHEN SHE WENT TO BED, HER BLOOD GLUCOSE WENT TO 21 MMOL/L. THEREFORE, WHEN SHE REMOVED THE INFUSION SET, SHE NOTICED THAT THE CANNULA WAS BENT. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 11.7 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 12360161 ↗
• MalfunctionMar 5, 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 THE PATIENT'S INFUSION SET'S TUBING HAD COME OFF AT THE TUBING CONNECTOR. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN, BUT THE INFUSION HAD NEVER BEEN USED. 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 11419182 ↗