Mio® MMT-941Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05705244007314), received between Jan 17, 2019 and May 12, 2021 — classified as 8 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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 29 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  UNOMEDICAL REFERENCE: (B)(4). A DIABETIC IS TREATED WITH INSULIN VIA A MEDTRONIC INSULIN PUMP AND A MEDTRONIC MINIMED MIO BLUE MMT-945 INFUSION SET. THE INFUSION SET IS MANUFACTURED BY UNOMEDICAL A/S. ON (B)(6) 2021 THE PATIENT EXPERIENCE ELEVATED BLOOD GLUCOSE AT 1200 MG/DL FOLLOWED BY A FALL AND CONCUSSION, PATIENT CALLS EMS AND THEN EXPERIENCE COMA. PATIENT IS TAKEN TO ER WHERE HE IS HOSPITALISED AT GROVE CITY HOSPITAL AND WAS IN COMA FOR SIX DAYS. PATIENT CLAIMS THAT THE HYPERGLYCEMIA AND THE FALL IS CAUSED BY THE INFUSION SET WHICH UNKNOWINGLY DETACHED. AT THE MEDTRONIC HELPDESK THE SUGGESTED TROUBLESHOOTING REGARDING THE DETACHMENT IS DECLINED BY THE PATIENT. DURATION OF THE USE OF THE INFUSION SET IN QUESTION IS UNKNOWN TO THE PATIENT. LOT/BATCH NUMBER IS UNKNOWN. NO FURTHER DETAILS ARE AVAILABLE. CAUSALITY, IN PARTICULAR TO THE COMA, REMAINS SOMEWHAT UNCLEAR.

  Patient problems: Coma; Hyperglycemia

  MAUDE report 11811724 ↗
• MalfunctionJan 27, 2021Detachment 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 26-APR-2021: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE AWARENESS DATE. MOREOVER, THE RESULT OF THE (COMPLAINT INVESTIGATIONS) VISUAL INSPECTION AND TESTS FOR CLICK AND STATIC PULL ON TUBING CONNECTOR WERE PERFORMED ON THE RETURNED USED DEVICE (ONE SET) WHICH SHOWED THAT ALL TEST RESULTS WERE 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 BY THE PATIENT'S PARENT THAT THEIR SON'S INFUSION SET'S TUBING WAS PULLED OUT ON THE NEEDLE AND TAPE PART. REPORTEDLY, IT SEEMED LIKE THE TUBING WAS NOT PROPERLY GLUED ON THE SITE PART. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11241547 ↗
• MalfunctionAug 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 10-AUG-2020, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME OUT OF THE SITE LOCATION, OVERNIGHT WHILE THE PATIENT WAS SLEEPING. SHE THINKS THAT SHE MIGHT HAVE ROLLED OVER THE TUBING WHICH MIGHT HAVE CAUSED SOME PULLING. THE SITE LOCATION WAS HER REAR BACK AND THE PUMP WAS LAID ON THE BED. MOREOVER, THE INFUSION SET 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. 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 10418928 ↗
• MalfunctionApr 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DISCONNECTED AT THE CONNECTOR WHILE SLEEPING WHICH LED TO HIGH BLOOD GLUCOSE LEVELS. THE SITE LOCATION WAS ON HER LEG AND THE PUMP WAS ON THE SAME SIDE AS THE SET. THE INFUSION HAD BEEN USED FOR TWO DAYS. THE INFUSIONS WERE IN A CUPBOARD IN THE HOUSE. SHE WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AND WAS ALSO UNSURE WHETHER THE PUMP WAS DROPPED WITH THE SET CONNECTED TO HER BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9961238 ↗
• MalfunctionMar 24, 2020Detachment 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 INFUSION SET'S TUBING DETACHED AT THE TUBING CONNECTOR WHILE SLEEPING. THE SITE LOCATION WAS ON HER LEG AND THE PUMP WAS LOCATED ON THE SAME SIDE, AS THE SET. FURTHER, THE INFUSIONS WERE STORED IN A CUPBOARD IN THE HOUSE. SHE WAS UNSURE OF ANY 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 Known Impact Or Consequence To Patient

  MAUDE report 9870814 ↗
• MalfunctionDec 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 06-MAR-2020: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE EXPIRATION DATE AND RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) WHICH SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PLASTIC IN THE NEEDLE CAME OFF WHILE THE PATIENT WAS SLEEPING. THE BLOOD GLUCOSE LEVEL FROM 28-OCT-2019 TO 31-OCT-2019, BETWEEN 10:26 PM TO 02:00 AM WAS 316 MG/DL AND FROM 15-NOV-2019 TO 18-NOV-2019, BETWEEN 10:38 AM TO 02:00 AM WAS 314 MG/DL. THE INFUSION SET'S TUBING CAME APART CLOSE TO THE SITE LOCATION. THE SITE LOCATION WAS ON THE TOP OF THE BACK SIDE OF PATIENT AND THE PUMP WAS WORN ON THE BELT. THE INFUSION HAD BEEN USED FOR ABOUT 3 DAYS. 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 THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9442796 ↗
• MalfunctionNov 30, 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 SITE WAS NOT FASTENING IN GOOD AT THE QUICK RELEASE AND IT GOT DETACHED FROM THE SITE WHILE HE WAS CHANGING HIS SET. FURTHER, THE TUBING WAS NOT HOOKING INTO WHERE HE WAS GETTING INSULIN, SO HE WAS NOT ABLE TO GET ANY INSULIN FOR TWO DAYS. ON (B)(6) 2019, THE INFUSION WAS CHANGED, AND THE PATIENT TRIED 3 TIMES AND IT DETACHED FROM THE SITE ALL THREE TIMES, SO THE INFUSION HAD BEEN USED FOR LESS THAN A DAY. THE SITE LOCATION WAS HIS ABDOMEN AND THE PUMP WAS ATTACHED TO BELT ON SAME SIDE AS SET. THE INFUSIONS WERE STORED IN A CLOSET ON TOP SHELF IN HIS HOME. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. REPORTEDLY, HE HAD DIFFICULTY IN BREATHING (SHORTNESS OF BREATH), WOOZY AND WAS NOT ALERT, AND HIS BLOOD GLUCOSE LEVEL WAS 1000 MG/DL (AT THE TIME OF INCIDENT). NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9392202 ↗
• MalfunctionNov 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'S MOTHER REPORTED THAT 3 DAYS PRIOR TO THE DAY OF REPORT (DATED (B)(6) 2018), IN THE MORNING HER SON'S INFUSION SET WAS CHANGED BEFORE SCHOOL. FURTHER, SHE STATED THAT HER SON'S INFUSION SET'S TUBING HAD DETACHED, WHILE SHE WAS UNWINDING THE TUBING. MOREOVER, THE PATIENT HAD LOT OF PAIN DURING INSERTION. REPORTEDLY, HIS BLOOD GLUCOSE WAS HIGH AROUND LUNCH TIME. UPON VISUAL INSPECTION, OF RETURNED USED DEVICES (1 SET / 1 SERTER), IT WAS FOUND THAT THE SET WAS DETACHED FROM THE TUBING CONNECTOR AND A DROP OF GLUE WAS FOUND ON TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 9294495 ↗
• InjurySep 20, 2019Material Twisted/Bent; Material Twisted/Bent

  ON 28-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICES (2 SETS) SHOWED THAT THE SOFT CANNULA WAS KINKED AT THE TIP AND IN THE OTHER 1 SET THE SOFT CANNULA WAS KINKED AT THE TIP AND THE PCC CONNECTOR NEEDLE WAS CLOGGED BY INSULIN. BASED ON THE RESULT: 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND BLOOD GLUCOSE LEVEL WAS HIGH AS 400 MG/DL. IT WAS REALIZED THAT THIS EVENT OCCURRED DUE TO A BENT CANNULA AND THE SITE LOCATION WAS HER RIGHT UPPER BUTTOCK AND HAD SUFFICIENT SUB-Q TISSUE WHERE SET WAS INSERTED. THEREFORE, THE ENTIRE SET WAS CHANGED AND DELIVERED INSULIN VIA PENS. REPORTEDLY, BENT CANNULA OCCURRED ON SECOND DAY OF USE. ON (B)(6) 2019, THE PATIENT WAS AT SCHOOL, THE PATIENT EXPERIENCED ABDOMINAL PAIN, VOMITING AND HER BLOOD GLUCOSE LEVEL READING WAS AROUND 405 MG/DL. MOREOVER, HER URINE TESTS INDICATED LARGE AMOUNTS OF KETONES DUE TO WHICH, ON THE SAME DAY AT 09:00 AM, THE PATIENT WAS IMMEDIATELY RUSHED TO THE EMERGENCY, WHERE THE SET PORTION O

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9096455 ↗
• MalfunctionSep 4, 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'S MOTHER REPORTED THAT INFUSION SET'S TUBING CAME STRAIGHT OUT OF THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING, DOING NOTHING OUT OF ORDINARY ROUTINE. THIS ISSUE OCCURRED THREE TIMES AND RECENTLY, LAST WEEK ON (B)(6) 2019, THE SAME ISSUE OCCURRED TWO TIMES. THE SITE LOCATION WAS AT PATIENT'S BUTTOCK AND THE PUMP WAS HOOKED ON HIS SIDE, TO HIS PANTS. THE INFUSION HAD BEEN IN USE FOR ONLY A DAY AND A HALF. REPORTEDLY, THE INFUSIONS WERE STORED INSIDE OF A CABINET IN THE HOUSE. THE PATIENT WAS UNSURE IF THERE WAS ANY STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HIS BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8959099 ↗
• MalfunctionAug 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 THAT WHILE SLEEPING, THE INFUSION SET'S TUBING DISCONNECTED FROM THE PLASTIC PART OF THE QUICK RELEASE, BETWEEN THE CANNULA AND TUBING CONNECTION. REPORTEDLY, THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 20.5 MMOL/L, WHICH HE TREATED WITH A BOLUS. THIS ISSUE OCCURRED ON THE SECOND DAY OF INFUSION USE. THE SITE LOCATION WAS AT PATIENT'S LEG AND THE PUMP WAS CLIPPED ON TO THE TROUSERS. THE INFUSIONS WERE STORED AT REGULAR TEMPERATURE. 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8938988 ↗
• InjuryAug 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  UNOMEDICAL REFERENCE: (B)(4). A MALE DIABETIC IS TREATED WITH INSULIN VIA A MEDTRONIC INSULIN PUMP AND A MEDTRONIC MIO PARADIGM MMT-941 INFUSION SET. ON (B)(6) 2019 HE EXPERIENCE ELEVATED BLOOD GLUCOSE AT 1064 MG/DL FOLLOWED BY COMA. PATIENT IS TAKEN TO ER WHERE HE IS HOSPITALISED (LAKE WEST HOSPITAL) AND IS IN COMA FOR TWO DAYS. PATIENT CLAIMS THAT THE HYPERGLYCEMIA, DKA AND COMA IS CAUSED BY THE INFUSION SET.

  Patient problems: Coma; Hyperglycemia

  MAUDE report 8849595 ↗
• InjuryJul 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  UNOMEDICAL REFERENCE: (B)(4). A MALE DIABETIC IS TREATED WITH INSULIN VIA A MEDTRONIC INSULIN PUMP AND A MEDTRONIC MIO PARADIGM MMT-941 INFUSION SET. HE ALSO USES A CGM SENSOR/TRANSMITTER. NOTE: HE IS NEW TO PUMP AND TO CGMS THERAPY. ON (B)(6) 2019 HE EXPERIENCE ELEVATED BLOOD GLUCOSE AT 400 MG/DL FOLLOWED BY SEIZURE. EMS TAKES PATIENT TO A HOSPITAL ((B)(6) HOSPITAL) WHERE HE IS IN COMA FOR THREE DAYS AND REMAIN HOSPITALIZED FOR TWO WEEKS. THERE ARE NO DATA INDICATING ANY PUMP FAILURE, INFUSION SET FAILURE OR SENSOR/TRANSMITTER FAILURE. IN EARLY JUNE IT IS STATED, THAT PATIENT 'IS STILL WORKING WITH HIS PHYSICIAN TO BE MORE AGGRESSIVE WITH HIS PUMP SETTINGS'.

  Patient problems: Coma; Hyperglycemia

  MAUDE report 8792538 ↗
• MalfunctionJun 3, 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 WHILE THE PATIENT WAS SLEEPING, THE TUBING CAME OUT AT THE QUICK RELEASE. THE SITE LOCATION WAS AT THE RIGHT SIDE OF HIS BELLY BUTTON. THE INFUSION HAD BEEN IN USE FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THERE WAS STRESS OR PULL ON THE TUBING WHILE THE PATIENT WAS SLEEPING 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 8661781 ↗
• MalfunctionMay 30, 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 ON THE DAY OF THIS REPORT, SHE CHANGED HER SITE AT LUNCHTIME. SHE WORKED, CAME HOME, SAT ON HER DESK AND WHEN SHE TOOK IT OUT OF HER POCKET FOR DINNER, THE TUBING WAS FOUND DETACHED FROM THE QUICK RELEASE. THE PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 74 MG/DL. THE SITE LOCATION WAS NEAR HER BELLY BUTTON ON THE RIGHT SIDE AND THE PUMP WAS IN HER RIGHT POCKET. THE INFUSION HAD BEEN IN USE FOR FOUR HOURS 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 8653222 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED HAVING FACED BENT CANNULA ISSUE DUE TO WHICH SHE EXPERIENCED VOMITING, DRY MOUTH, LETHARGY ABOUT TWO MONTHS BEFORE THIS REPORT. SHE ALSO HAD DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 512 MG/DL AT THE TIME OF INCIDENT, WHICH SHE SELF-TREATED WITH PUMP AND INJECTIONS. SUBSEQUENTLY, SHE WENT TO THE EMERGENCY ROOM AND WAS LATER HOSPITALIZED. THE PATIENT RECEIVED FLUIDS VIA INTRAVENOUS ROUTE AND INSULIN AS CORRECTIVE TREATMENT. WHILE AT THE HOSPITAL, THE BLOOD GLUCOSE LEVEL CAME DOWN, BUT IT KEPT GOING BACK UP AND WAS UP MOST OF THE TIME. THE PATIENT STAYED IN THE HOSPITAL FOR THREE DAYS. PATIENT'S BLOOD GLUCOSE LEVEL ON THE DAY OF THIS REPORT WAS 165 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 8543352 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT HAD EXPERIENCED AN ISSUE WITH THE INFUSION SET IN THE FORM OF BENT CANNULA. HE STATED THAT IT HAPPENED EARLIER ALSO, WHERE THE CANNULA DID NOT GO ALL THE WAY IN AND IT WAS BENT, AND HE HAD TO CHANGE IT AND HE STATED THAT MOST LIKELY THE SAME THING HAPPENED AGAIN. REPORTEDLY, HE HAD INCREASED BLOOD GLUCOSE LEVELS IN THE PAST FIVE DAYS, EXPERIENCED DIABETIC KETOACIDOSIS AND HAD ABDOMINAL PAIN WHICH LED TO HOSPITALIZATION. IT WAS REPORTED BY THE NURSE AT THE HOSPITAL, THAT THE PATIENT FORGOT HIS INSULIN PUMP AT THE TRIP AND WAS ADMITTED AS HIS BLOOD GLUCOSE WERE OUT OF CONTROL. CURRENTLY, HE WAS IN THE HOSPITAL, A LITTLE OVER A WEEK AND WAS BEING TREATED WITH INSULIN PER SYRINGE. HIS CURRENT BLOOD GLUCOSE WAS 238 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 8517277 ↗
• MalfunctionApr 9, 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 TUBING CAME OUT OF CLIP AT QUICK RELEASE CONNECTOR WHILE SLEEPING. THE PATIENT SHOT WITH PEN AND GOT THE SITE ON. THE SITE WAS AT THE UPPER HIP AND THE PUMP WAS ON THE SAME SIDE IN RELATION WITH THE SITE. 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. THE PATIENT WAS UNCERTAIN WHETHER THERE WAS STRESS OR PULL ON THE TUBING AS THE PUMP MIGHT FELL OUT OF POCKET AND WAS HANGING OFF THE BED. THE PATIENT WAS UNSURE WHETHER THE PUMP WAS DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8494817 ↗
• MalfunctionApr 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). THE PATIENT REPORTED HAVING EXPERIENCED TUBING DETACHMENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490312 ↗
• MalfunctionApr 7, 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 INFUSION SET TUBING WAS DETACHED WHILE THE PATIENT WAS INSERTING THE INFUSION SET. THE SITE LOCATION WAS PATIENT'S TUMMY. THE PUMP WAS WORN ON THE OPPOSITE SIDE. THE INFUSION HAD BEEN IN USE FOR LESS THAN 1 HOUR 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 8489909 ↗
• MalfunctionApr 5, 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'S MOTHER REPORTED THAT THE INFUSION SET TUBING HAD DETACHED WHILE HIS SON WAS AT SCHOOL. THE SITE LOCATION WAS PATIENT'S BELLY AND LOWER BACK. THE PUMP WAS WORN ON HIS BELT AND THE OTHER TIMES ON HIS POCKET. THE INFUSION HAD BEEN IN USE FOR LESS THAN 24 HOURS AND THE INFUSIONS WERE STORED AT ROOM TEMPERATURE. THERE WAS 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 8486254 ↗
• 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'S MOTHER REPORTED THAT THE TUBING KEPT COMING OUT OF ITS CLIP AND DETACHMENT OCCURRED WHERE THE CLEAR BLUE PIECE CAME OUT OF BLUE HOUSING WHILE THE PATIENT WAS AT SCHOOL. THIS WAS THE THIRD TIME THAT THE TUBING CAME OFF. THE SITE LOCATION WAS AT THE BOTTOM AND THE PUMP WAS LOCATED ON THE HIP/BELT. THE INFUSION WAS IN USE FOR COUPLE OF HOURS. 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 THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8467971 ↗
• MalfunctionMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S FATHER REPORTED THAT THE TUBING CAME LOOSE AT THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8463035 ↗
• MalfunctionMar 25, 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 IN THE MORNING OF THIS REPORT, QUICK RELEASE FELL OFF THE INFUSION SET CANNULA. AT THE TIME OF THIS INCIDENT, BLOOD GLUCOSE LEVEL WAS AT 116 MG/DL. 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 8447458 ↗
• MalfunctionMar 18, 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 TUBING DETACHED AT THE QUICK RELEASE AND THE PATIENT OBSERVED INSULIN OUT OF THE TUBING ABOUT 12 HOURS AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH FIVE SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8427773 ↗