Mio® MMT-965Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05705244007796), received between Dec 20, 2018 and Aug 26, 2026 — classified as 9 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient faced insulin flow blocked alarm event on (b)(6) 2024 and patient experienced low BG (24mg/dl) and treated with Intravenous glucose treatment.

  Patient problems: Hypoglycemia

  MAUDE report 50450612 ↗
• MalfunctionAug 25, 2021Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  ON (B)(6) 2022: FOLLOW UP INFORMATION WAS SUBMITTED TO ADD DATE OF THIS REPORT AND TO UPDATE THE AWARENESS DATE. MOREOVER, THE RESULT OF COMPLAINT INVESTIGATION OF RETURNED USED DEVICE (ONE INTRODUCER NEEDLE), SHOWED THAT THE VISUAL TEST RESULT WAS WITHIN SPECIFICATIONS. BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DISCONNECTED AT THE SITE WHILE INSERTING THE SET. THE SITE LOCATION WAS HER ABDOMEN, AND THE PUMP WAS NOT USED YET. THE INFUSION SETS WERE STORED IN A 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. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 134 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12364200 ↗
• InjuryJul 21, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT WHILE THE PATIENT WAS TAKING A SHOWER, THE INFUSION SET'S TAPE HAD GOTTEN LOOSE AND FELL OFF. FURTHER, SHE COULD NOT PUT IT BACK AND SHE STARTED RUNNING HIGH, AS SHE DID NOT USE THE PUMP. HER BLOOD GLUCOSE LEVEL WENT UP TO 1100 MG/DL AND HER HUSBAND CALLED THE AMBULANCE. ON (B)(6) 2020, BETWEEN 11:00 AM - 12:00 PM, THE PATIENT WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVEL OF 1100 MG/DL. DURING HOSPITALIZATION, SHE RECEIVED INTRAVENOUS INSULIN DRIP AS CORRECTIVE TREATMENT AND AFTER SPENDING 2 NIGHTS AND 3 DAYS, SHE WAS RELEASED FROM THE HOSPITAL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10300441 ↗
• MalfunctionMay 27, 2020Detachment 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 TUBE CAME OUT FROM WHERE IT WAS CONNECTED TO THE BODY (DETACHED), ALTHOUGH THE TUBE FROM THE PUMP WAS CONNECTED. REPORTEDLY, THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS OF 250 MG/DL, AS THE INSULIN WAS NOT BEING DELIVERED. THE SITE LOCATION WAS HIS ABDOMEN. THEY ARE UNSURE IF THERE WAS ANY STRESS OR PULL ON THE TUBING AND WERE ALSO UNSURE IF THE PUMP WAS DROPPED WITH THE SET CONNECTED TO THEIR BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10090604 ↗
• MalfunctionMay 26, 2020Detachment 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 TUBING DETACHED (FELL OFF). HE HAD THE FAILED INFUSION SET LAST 2 WEEKS. THE SITE LOCATION WAS HIS ABDOMEN AND THE PUMP WAS WORN. THE INFUSION HAD BEEN USED FOR TWO TO THREE DAYS. 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 BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10085931 ↗
• MalfunctionFeb 19, 2020Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET CAME UNDONE FROM HER BODY WHILE SLEEPING. FURTHER, IT WAS STATED THAT THE INFUSION SET'S TUBING CAME APART, AS IT CAME OUT OF THE SKIN WHICH LED TO HIGH BLOOD GLUCOSE LEVELS. THE SITE LOCATION WAS HER STOMACH AND THE PUMP WAS LOCATED ON THE SAME SIDE. THE INFUSION HAD BEEN USED FOR MAYBE ONE DAY AND THEY WERE STORED IN A DRESSER. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THEIR BODY. REPORTEDLY, THE PATIENT HAD A SURGERY (NON-DIABETIC). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9725608 ↗
• MalfunctionJan 27, 2020Detachment 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 ABOUT A DAMAGED INFUSION SET FROM THE PACKAGE. AS THE PATIENT OPENED THE SHELL OF THE INFUSION SET, WHILE UNFURLING, THE TUBING HUNG UP AND TANGLED. THE PATIENT NOTICED THAT THE END OF THE TUBING THAT SHOULD HAVE BEEN CONNECTED TO THE QUICK RELEASE, WAS LOOSENED AND GOT DETACHED. MOREOVER, THE PATIENT HAD NOT USED THE INFUSION SET AND THE EVENT OCCURRED PRIOR TO USE. 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 Known Impact Or Consequence To Patient

  MAUDE report 9630799 ↗
• MalfunctionJan 21, 2020Detachment 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'S TUBING BROKE APART WHEN THEY WERE TRYING TO CHANGE THE SET. REPORTEDLY, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET IN PLACE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9609343 ↗
• InjuryDec 18, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT THE PATIENT FELT NAUSEOUS, HAD DIFFICULTY IN BREATHING, CHEST PAIN AND HE FACED A BENT CANNULA ISSUE. PATIENT'S BLOOD GLUCOSE LEVEL WAS 629 MG/DL AT THE TIME OF INCIDENT. THEREFORE, ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 629 G/DL AND DIABETIC KETOACIDOSIS, WHERE HE WAS TREATED WITH INSULIN DRIP. AT THE TIME OF THIS REPORT ((B)(6) 2019), THE PATIENT WAS STILL IN THE HOSPITAL. 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 9486473 ↗
• InjuryDec 9, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE FELT NAUSEOUS, HAD ABDOMINAL PAIN, DIFFICULTY IN BREATHING, POSITIVE IN KETONES TEST AND DID NOT FELT GOOD. FURTHER, SHE HAD HIGH BLOOD GLUCOSE LEVEL IN THE RANGE OF 272-289 MG/DL, WHICH SHE TRIED TO TREAT IT WITH MANUAL SYRINGES. REPORTEDLY, HER BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL AT THE TIME OF THIS EVENT. ON (B)(6) 2019, SHE HAD A BENT CANNULA. SUBSEQUENTLY, SHE WAS SENT TO THE EMERGENCY ROOM ON (B)(6) 2019 (BETWEEN 7 AM AND 8 AM), DUE TO DIABETIC KETOACIDOSIS. CONSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH TWO INTRAVENOUS TREATMENT (DRUG NAME UNKNOWN) AND INSULIN IMMEDIATELY. THE SITE LOCATION WAS HER ABDOMEN. THE PATIENT WAS ADMITTED FOR THREE DAYS. IN THE MORNING OF THIS REPORT ((B)(6) 2019), THE PATIENT'S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AND SHE CHANGED HER SET 4-5 TIMES OVER THE LAST 12 HOURS. UPON REMOVAL OF THE SET, THE CANNULA WAS FOUND TO BE BENT AGAIN. MOREOVER, SHE GAVE HERSELF 4 MANUAL INJECTIONS TO LOWER DOWN HER BLOOD GLUCOSE LEVEL AND ADDITIONAL BOLUS OF 8 UNITS TO ENSURE THAT HER BLOOD GLUCOSE LEVEL WILL GO DOWN. UNOMEDICAL DO NOT S

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9442769 ↗
• MalfunctionOct 24, 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 ON (B)(6) 2018, THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED ON THE INSIDE WHERE THE TUBING UNCOILS, WHILE THE PATIENT WAS UNWINDING THE INFUSION SET BEFORE INSERTION. REPORTEDLY, THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS. THE INFUSION WAS NOT BEING PUT ON YET AND THE PUMP WAS NOT BEING WORN AT THAT TIME. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE GLUE IN THE TUBING CONNECTOR WAS MISSING, ALSO A DROP OF GLUE ON TUBING CONNECTOR WAS FOUND. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9236688 ↗
• InjuryOct 15, 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 SON EXPERIENCED NAUSEA, VOMITING, ABDOMINAL PAIN, DIFFICULTY IN BREATHING AND WALKING, AND HAD HIGH BLOOD GLUCOSE LEVELS WHICH LED TO DIABETIC KETOACIDOSIS. CONSEQUENTLY, ON (B)(6) 2019 AT 11 PM, THE PATIENT WAS ADMITTED INTO THE INTENSIVE CARE UNIT WITH A BLOOD GLUCOSE LEVEL OF 600 MG/DL AND DIABETIC KETOACIDOSIS (POSITIVE RESULTS FOR THE KETONE TEST). FURTHER, THE PATIENT'S MOTHER REPORTED THAT AFTER REMOVING THE INFUSION SET, IT WAS FOUND THAT THE CANNULA WAS BENT. THE INFUSION HAD BEEN IN USE FOR ONE DAY AND THE SITE LOCATION WAS THE PATIENT'S ABDOMEN. DURING HOSPITALIZATION, HE WAS TREATED WITH A PUMP AND A MANUAL INJECTION AS A CORRECTIVE 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 9189870 ↗
• MalfunctionOct 7, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) -2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT ALL THE TEST RESULT WERE WITHIN SPECIFICATIONS. BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT'S INFUSION SET'S TUBING CAME AWAY FROM THE SET, AS IT DETACHED FROM THE SITE LOCATION, WHILE SLEEPING ON THE CHAIR. HER BLOOD GLUCOSE WAS REPORTED TO BE APPROXIMATELY ABOVE 300 MG/DL AND SHE SELF-TREATED IT BY 9 UNITS OF INSULIN WITH THE PUMP. THE INFUSION WAS CHANGED ON (B)(6) 2019 AND THEY WERE STORED IN A DRESSER. REPORTEDLY, ON (B)(6) 2019 (AT THE TIME OF THIS REPORT), THIS ISSUE OCCURRED AGAIN. AS THE PATIENT WOKE UP, SHE DID NOT FEEL GOOD AND HER BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 450 MG/DL. THE INFUSION HAD BEEN IN USE FOR THREE DAYS. THE SITE LOCATION WAS ON LEFT SIDE OF HER TUMMY AND THE PUMP WAS ON THE RIGHT SIDE. THE PATIENT WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. AT THE TIME OF THIS REPORT ((B)(6) 2019

  Patient problems: Hyperglycemia

  MAUDE report 9160615 ↗
• InjuryMay 17, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT FACED BENT CANNULA ISSUE IN 8 OR 9 INFUSION SETS IN THE TWO MONTHS PRIOR TO THIS REPORT. DUE TO THIS, SHE WAS NOT GETTING ANY INSULIN AND HAD BEEN VOMITING FOR FOUR DAYS. SHE CHANGED SITES AND TOOK A TRIP FOR FOUR HOURS. WHEN SHE RETURNED, SHE FELT VERY TIRED AND WAS VOMITING. SHE HAD HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 675 MG/DL, AT THE TIME OF THIS INCIDENT, WHICH SHE TRIED TO SELF-TREAT WITH A BOLUS. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL DUE TO DIABETES KETOACIDOSIS AND BLOOD GLUCOSE LEVEL WAS 119 MG/DL, AT THE TIME OF HOSPITALIZATION. HER BLOOD GLUCOSE LEVEL WAS MONITORED EVERY HOUR AND SHE WAS GIVEN INSULIN IN THE HOSPITAL. ADDITIONALLY, HER WHITE BLOOD CELLS COUNT AND TRIGLYCERIDES WERE BROUGHT BACK TO NORMAL. THE PATIENT WAS HOSPITALIZED 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 8618574 ↗
• InjuryApr 26, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT EXPERIENCED DIABETES KETOACIDOSIS AND TRIED TO PUT 10 UNITS OF INSULIN EVERY HOUR BUT NOTHING HAD HAPPENED, AS HIS BLOOD GLUCOSE LEVEL DID NOT COME BELOW 600 MG/DL. WHEN HE REMOVED THE INFUSION SET, THE CANNULA WAS FOUND TO BE BENT. THE PATIENT REPLACED THIS SET AND NOTICED THAT THE SECOND ONE WAS ALSO BENT. HIS BLOOD GLUCOSE LEVEL WAS 958 MG/DL AT THE TIME OF INCIDENT WHICH HE SELF-TREATED WITH SHOTS. THE PATIENT WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS AND RECEIVED INSULIN VIA INTRAVENOUS ROUTE, AS CORRECTIVE TREATMENT UNTIL HE WAS STABLE ENOUGH TO BE DISCHARGED. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 171 MG/DL AND HE WAS HOSPITALIZED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8553549 ↗
• MalfunctionApr 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT THE TUBING POPPED OFF FROM THE QUICK RELEASE AND THE NEEDLE BROKE OFF DURING THE INSERTION PROCESS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8525830 ↗
• MalfunctionApr 11, 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 TUBING HAD DETACHED AT THE QUICK RELEASE. THE SITE LOCATION WAS PATIENT'S OUTER THIGH. THE PUMP WAS WORN ON THE PATIENT'S BELT LINE. THE INFUSION HAD BEEN IN USE FOR A FEW MINUTES AND 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 8502622 ↗
• MalfunctionApr 8, 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 WHILE THE PATIENT CHANGED THE INFUSION SET, ITS TUBING DETACHED CLOSED TO THE QUICK RELEASE/SITE CONNECTOR. REPORTEDLY, THE TUBING DISCONNECTED AT THE SITE AND THE TUBING CAME OFF THE CLASP WHILE THE CLASP REMAINED THERE. THE SITE WAS ON THE LEFT SIDE OF THE WAIST ON THE BACK AND THEN WAS ON THE LEFT BUTT. THE INFUSION WAS IN USE FOR A DAY, AS THE INFUSION SET WAS INSERTED. IT WAS UNSURE, WHETHER THE INFUSIONS WERE 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. IT WAS UNSURE WHETHER THE PUMP WAS 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 8490441 ↗
• MalfunctionApr 8, 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 NIGHT BEFORE THIS REPORT, WHILE SLEEPING THE TUBING BROKE OFF AT THE QUICK RELEASE. HOWEVER, THE PATIENT NOTICED TUBING DETACHMENT UPON WAKING UP AND BLOOD GLUCOSE LEVEL WAS 487 MG/DL, HE CHANGED THE SET AND SITE. HE SELF-TREATED WITH PUMP AND WAS ALSO ON TEMPORARY BASAL. HW WAS ALSO TRYING TO GET KETONE LEVEL DOWN. THE SITE LOCATION WAS AT RIGHT SIDE OF THE ABDOMEN AND THE PUMP WAS CLIPPED ONTO PANTS ON RIGHT SIDE. THE INFUSION HAD BEEN IN USE FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE STORED IN AIR-CONDITIONED SPACE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 387 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8490161 ↗
• MalfunctionApr 7, 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 CAME APART AND THE PUMP WAS DROPPED WITH THE SET-IN PLACE. THERE WAS LEAKAGE ON HER SET AT THE ADHESIVE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8489915 ↗
• 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 WAS DUE TO BE CHANGED WHEN HE WAS ABOUT TO PULL BACK THE SERTER TO LOCK IT IN PLACE DURING INSERTION AND THE TUBING DETACHED BY THE QUICK RELEASE WHILE IT WAS STILL IN THE SERTER. SO, HE HAD TO START OVER AGAIN WITH A NEW SET. 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. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR DUE TO MISSING GLUE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468004 ↗
• 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 INFUSION SET WAS NOT ATTACHED TO THE NEEDLE PORTION AND WAS DETACHED AT THE SITE PORTION. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. UPON INVESTIGATION, IT WAS FOUND THAT THERE WAS MISSING GLUE IN THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8468001 ↗
• MalfunctionMar 27, 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 TUBING HAD DETACHED FROM THE INFUSION PATCH. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8457447 ↗
• InjuryFeb 15, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHILE INSERTION OF THE CANNULA UNDER THE SKIN, THE CANNULA BENT WHICH CAUSED DIABETES KETOACIDOSIS AND LAID TO HOSPITALIZATION. THIS ISSUE OCCURRED WITH FOUR SETS AND ALL THE SETS LASTED FOR A DAY. THE CONCERNED SET DID NOT LAST FOR A DAY AND SHE WAS HOSPITALIZED, WHERE THEY FOUND OUT THAT THE CANNULA WAS BENT WHICH MIGHT BE THE CAUSE OF HER HIGH BLOOD GLUCOSE LEVEL (395 MG/DL). HER ROOMMATE CHANGED THE SET THAT TIME. PATIENT ALSO HAD ACUTE KIDNEY INJURY. SHE WANTED A NEW BELT CLIP AS THE PREVIOUS GOT BROKE. THE PATIENT WAS PUT ON PHOSPHOROUS STRIPS, SMALL DOSE OF MORPHINE AND INSULIN AS CORRECTIVE TREATMENT. REPORTEDLY, THE ISSUE WAS RESOLVED BY INFUSION CHANGE. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 188 MG/DL. 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 8342177 ↗
• MalfunctionJan 28, 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 HE HAD AN ISSUE WITH FAULTY INFUSION SETS FOR 2/3 DAYS AND REMOVED THE INFUSION FROM THE SITE SINCE THEN. REPORTEDLY, THE TUBING DETACHED FROM THE CANNULA PORTION OF HIS INFUSION SET AT QUICK RELEASE. THE PATIENT HAD THIS ISSUE SOMETIMES PRIOR TO INSERTION AND SOMETIMES WHEN HE HAD RISE IN BLOOD GLUCOSE LEVEL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8283946 ↗