Quick-set® Paradigm® MMT-387Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 05705244006492), received between Feb 5, 2018 and Sep 29, 2026 — classified as 2 deaths, 7 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (54 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 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hyperglycemia

  MAUDE report 50932416 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had high blood glucose and treated with bolus on (b)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 50470569 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that patient had high blood glucose and treated with bolus on (b)(6) 2026.

  Patient problems: Hyperglycemia

  MAUDE report 50470543 ↗
• MalfunctionMay 28, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2021, THE PATIENT REPORTED THAT WHEN SHE WOKE UP, SHE NOTICED THAT THE PUMP WAS NOT ATTACHED TO HER AND WHEN SHE WENT BACK TO THE BED SHE FOUND THAT HER INFUSION SET'S TUBING BROKE IN HALF AT THE MIDDLE OF THE TUBING. THIS ISSUE OCCURRED WHILE THE PATIENT WAS SLEEPING. FURTHER, THE SITE LOCATION WAS HER STOMACH AND THE PUMP WAS LOCATED NEXT TO HER. MOREOVER, THE INFUSION SETS 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. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 210 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899829 ↗
• MalfunctionSep 30, 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 WHEN THE PATIENT WOKE UP, IT WAS NOTICED THAT THE TUBING ON THE INFUSION SET HAD A CRACK AND IT WAS NOTICED TWO DAYS AGO, AS THE PATIENT FELT ROUGH ON THE TUBING AND IT HAD CRACKS ON TWO DIFFERENT PLACES. FURTHER, THE PATIENT WAS NOT MOVING A LOT BECAUSE OF A BROKEN HIP. IT DID NOT FEEL LIKE IT WAS FLEXIBLE AND NOT RUBBERY UNLIKE WITH THE PREVIOUS ONE BEFORE AND WAS STIFF AND ROUGH NOW. THE PATIENT HAD THIS ISSUE WITH MULTIPLE INFUSION SETS (2 OUT OF 10 INFUSION SET HAD THIS ISSUE). THE SITE LOCATION WAS ON THE PATIENT'S ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR TWO DAYS. THE INFUSIONS WERE STORED AT THE ROOM TEMPERATURE. FURTHER, THE 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, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 187 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10604887 ↗
• InjuryJan 21, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, ABDOMINAL PAIN, DIFFICULTY IN BREATHING AND HAD POSITIVE RESULTS FOR KETONE TEST. REPORTEDLY, THE SHE WAS HAVING ISSUES WITH HER INFUSION SETS, WHERE THE CANNULA KEPT ON KINKING/BENDING AND WHICH WAS THE PROBABLE CAUSE OF HER HYPERGLYCEMIC EPISODES. HER BLOOD GLUCOSE LEVEL WAS 33.3 MMOL/L AT THE TIME OF INCIDENT. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL OF 33.3 MMOL/L DUE TO DIABETIC KETOACIDOSIS, WHERE SHE RECEIVED INTRAVENOUS INSULIN, ANXIETY MEDICATION AND ANTIBIOTICS (DRUG NAME UNKNOWN). ON THE DAY OF THIS REPORT ((B)(6) 2020), THE PATIENT WAS STILL HOSPITALIZED, AND HER CURRENT BLOOD GLUCOSE LEVEL WAS 7.7 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 9609378 ↗
• MalfunctionDec 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 WHEN HE GOT HOME FROM WORK, IN THE EVENING OF (B)(6) 2019, THE INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE. REPORTEDLY, THE SITE LOCATION WAS HIS ABDOMEN AND THE PUMP WAS ON HIS SIDE ON THE BELT CLIP. 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 9449066 ↗
• MalfunctionDec 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 AT THE QUICK RELEASE AND DOES NOT KNOW HOW IT HAD HAPPENED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9393474 ↗
• InjuryNov 20, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, DIFFICULTY IN BREATHING AND GOT CRACKED RIBS BECAUSE OF BREATHING ISSUES. FURTHER, HIS BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL, WHICH HE TRIED TO TREAT WITH A BOLUS. IN THE MORNING OF (B)(6) 2019, THE BLOOD GLUCOSE LEVELS WERE REPORTED TO BE 570 MG/DL, 410 MG/DL AND 161 MG/DL (AT 11:32 AM). THE INFUSION SET WAS CHANGED ON (B)(6) 2019, SITE LOCATION WAS RIGHT SIDE. REPORTEDLY, ON (B)(6) 2019 (FRIDAY), HE WAS NOT GETTING INSULIN, SO HIS WIFE BROUGHT HIM TO THE EMERGENCY ROOM. HIS BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL, THEN IT WENT DOWN TO 400 MG/DL, WHEN HE GOT TO THE HOSPITAL. UPON REMOVAL OF THE INFUSION SET, IT WAS FOUND TO BE BENT. DURING HOSPITALIZATION, HE RECEIVED INSULIN INJECTIONS AS CORRECTIVE TREATMENT. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 327 MG/DL AND HE WAS STILL IN THE HOSPITAL AS PER REPORT DATED 28-OCT-2019. 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9345926 ↗
• MalfunctionNov 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IN THE MORNING OF (B)(6) 2019, AROUND 7:00-7:30 AM, AS THE PATIENT WOKE UP, IT WAS FOUND THAT THE INFUSION SET'S TUBING HAD COME APART WHERE IT HOES INTO THE HOSE, LAST NIGHT WHILE SLEEPING. REPORTEDLY, THE DETACHMENT OCCURED AT THE QUICK RELEASE/ SITE CONNECTOR AND THE BLOOD GLUCOSE LEVEL WAS 364 MG/DL. THE SITE LOCATION WAS RIGHT SIDE OF LOWER STOMACH AND THE PUMP WAS ON THE SAME SIDE. THE INFUSION HAD BEEN USED FOR ONE DAY. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. 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. THIS WAS THE SECOND TIME THAT IT HAD HAPPENED TO IN THE PAST 2 WEEKS. UPON INVESTIGATION, OF THE RETURNED USED DEVICE (1 INSERTED SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9345871 ↗
• 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. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING HAD DETACHED FROM HER SITE AT THE QUICK RELEASE/ CONNECTOR, WHICH LED TO INCREASED BLOOD GLUCOSE LEVELS, WHILE SHE WAS IN THE CLASS. THE SITE LOCATION WAS LEFT SIDE OF HER ABDOMEN AND THE PUMP WAS LOCATED ON THE SAME SIDE. THE INFUSION WAS BEING USED FOR LESS THAN A DAY. 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 OF RETURNED USED DEVICE (1 SET), 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 9236692 ↗
• DeathSep 23, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER: (B)(4). WIFE REPORTED THAT MALE DIABETIC PATIENT ON PUMP THERAPY HAS PASSED AWAY. REPORTED INFUSION SET TUBING KINKED AND HIS BLOOD SUGARS WENT TO OVER 1000 MG/DL BY THE TIME HE THEY GOT TO HOSPITAL HE WAS IN DKA AND PASSED AWAY SHORTLY AFTER. DATE OF HOSPITALIZATION AND DEATH UNKNOWN. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Death

  MAUDE report 9102726 ↗
• MalfunctionSep 2, 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 HAD DETACHED AT THE QUICK RELEASE. THE PATIENT NOTICED INSULIN COMING OUT OF THE TUBING ABOUT ONE DAY AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH SEVERAL SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953291 ↗
• MalfunctionAug 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHEN SHE WOKE UP, SHE FOUND THAT THE INFUSION SET'S TUBING HAD COME OUT OF THE SITE PORTION. FURTHERMORE, THE CANNULA PORTION OF THE SET STAYED IN ALONG WITH THE QUICK RELEASE, BUT THE TUBING HAD COME OFF THAT AREA. THIS ISSUE OCCURRED TWICE WHILE SLEEPING IN FIVE DAYS AND BOTH THE SETS WERE FROM THE SAME BOX. THE SITE LOCATION WAS HER THIGH AND THE PUMP WAS HOOKED TO HER SLEEPING SHORTS. THE INFUSION WAS USED FOR ONE AND A HALF DAY FOR THE FIRST SET AND TWO DAYS FOR THE SECOND SET. THE INFUSIONS WERE STORED IN THE KITCHEN ON THE COUNTER. REPORTEDLY, THE PATIENT WAS UNSURE OF ANY STRESS OR PULL ON THE TUBING AS SHE WAS ASLEEP AT THE TIME 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 8905099 ↗
• MalfunctionAug 7, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 06-FEB-2020: FOLLOW UP INFORMATION WAS SUBMITTED FOR EXPIRATION DATE AND LOT NUMBER. ALSO, THE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) 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. THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED WHILE SHE WAS SLEEPING. IN THE MORNING OF (B)(6) 2019, THE PATIENT WOKE UP WITH BLOOD GLUCOSE LEVEL AT 265 MG/DL. THIS ISSUE OCCURRED WITH TWO INFUSION SETS. THE SITE LOCATION WAS PATIENT'S LEFT ARM AND THE PUMP WAS LOCATED ON THE BELT AREA. THE INFUSION HAD BEEN IN USE FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE USED AS NORMAL. THERE WAS STRESS OR PULL ON THE TUBING WHILE SHE WAS SLEEPING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. AT THE TIME OF THIS REPORT, THE PATIENT WAS STABLE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8868663 ↗
• MalfunctionJul 19, 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 TWO INFUSION SETS, THE TUBING THAT WENT INTO THE PLASTIC PIECE, WHICH FURTHER WENT INTO THE PATIENT BROKE OFF. THE LOCATION OF DETACHMENT WAS AT THE QUICK RELEASE. THIS ISSUE OCCURRED FOR THE FIRST TIME WHILE THE PATIENT WAS SLEEPING AND THE SECOND TIME, WHEN THE PATIENT WAS JUST OUT AND ABOUT. THE SITE LOCATION WAS PATIENT'S LEFT AND RIGHT LEG, RESPECTIVELY. THE INFUSION HAD BEEN IN USE FOR TWO 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. UPON INVESTIGATION OF THE RETURNED USED DEVICES (2 TUBES), IT WAS FOUND THAT THE TUBES WERE DETACHED FROM THE TUBING- TUBING CONNECTORS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8806283 ↗
• 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 PATIENT'S INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN COMING OUT OF THE TUBING ABOUT 6 HOURS AFTER THE SET WAS CHANGED. THIS ISSUE OCCURRED WITH ONE SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8726274 ↗
• MalfunctionJun 17, 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'S TUBING CAME APART FROM THE SITE. HER BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 400 MG/DL AT THE TIME OF INCIDENT. THE PATIENT WAS EMOTIONAL AND VERY UPSET. SHE STATED THAT DETACHMENT OCCURRED ON THE DAY OF THIS REPORT AND SHE HAD BEEN RUNNING HIGH SINCE THE PREVIOUS DAY. THE SITE LOCATION WAS PATIENT'S ARM AND THE PUMP WAS LOCATED BELOW THE INFUSION. THE INFUSION HAD BEEN IN USE FOR A DAY AND A HALF. THE INFUSIONS WERE STORED IN A DRY PLACE. 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 8702737 ↗
• MalfunctionMay 17, 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 AT THE QUICK RELEASE WOULD NOT CONNECT PROPERLY AND IT CAME APART. THE PATIENT'S BLOOD GLUCOSE LEVEL REACHED ABOVE 500 MG/DL AND WAS FLUCTUATING. THE SITE LOCATION WAS LEFT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS ON THE SAME SIDE IN THE POCKET. THE INFUSION HAD BEEN IN USE FOR AT LEAST A DAY 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: Hyperglycemia

  MAUDE report 8618521 ↗
• MalfunctionMay 14, 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 WAS REMOVED AND INFUSION SET DETACHED WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S LEG AND THE PUMP WAS CLIPPED ON HER BRA. THE INFUSION HAD BEEN IN USE FOR 3 DAYS. REPORTEDLY, THE PATIENT WAS AT HOME AND SHE DID NOT REALIZE WHEN IT FELL APART. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. HER BLOOD GLUCOSE LEVEL WAS 286 MG/DL AND WEIGHT WAS (B)(6) LBS AT THE TIME OF REPORTING. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8606954 ↗
• MalfunctionMay 3, 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 DETACHED FROM THE TUBING CONNECTOR WHILE THE PATIENT WAS PULLING PANTS OFF EITHER DURING WORK OR SLEEP. THE SITE LOCATION WAS PATIENT'S THIGH AND THE PUMP WAS LOCATED ON THE RIGHT SIDE. THE INFUSIONS WERE STORED IN THE 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: No Known Impact Or Consequence To Patient

  MAUDE report 8576737 ↗
• MalfunctionMay 3, 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 SLEEPING, THE INFUSION SET'S TUBING BROKE OFF FROM THE CONNECTION. REPORTEDLY, THE TUBING HAD DISCONNECTED CLOSE TO THE QUICK RELEASE AND IT PULLED RIGHT OUT OF THE SITE. THE SITE LOCATION WAS PATIENT'S ARM AND THE PUMP WAS ON THE PATIENT'S HIP. THE INFUSION WAS USED FOR ONE DAY 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 8576473 ↗
• InjuryMay 2, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT ONE OF HIS INFUSION SETS GOT KINKED. SUBSEQUENTLY, THE PATIENT DID NOT FEEL WELL, AND SOMEONE TOOK HIM TO THE HOSPITAL. WHEN ADMITTED TO THE HOSPITAL, HIS BLOOD GLUCOSE LEVELS WERE BETWEEN 492 TO 500 MG/DL, EXPERIENCED DIABETIC KETOACIDOSIS AND HAD BENT CANNULA. REPORTEDLY, HE WAS PUT ON HIS PUMP BACK. HE WAS BEING HOSPITALIZED FOR THREE DAYS AND WAS STILL IN THE HOSPITAL 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. 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 8572766 ↗
• MalfunctionApr 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT IN THE MORNING OF THIS REPORT WHEN THE PATIENT WOKE UP, THE TUBING WAS DISCONNECTED FROM THE QUICK RELEASE WHILE SLEEPING AND COULD SEE THE GLUE. PATIENT'S BLOOD GLUCOSE LEVEL WAS 250 MG/DL AND TREATED IT WITH MANUAL INJECTION WITH A SYRINGE. THE SITE LOCATION WAS AT THE THIGH AND THE PUMP WAS CONNECTED TO THE PANTS. THE INFUSION HAD BEEN IN USE FOR TWO 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. IN THE INVESTIGATION IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8560560 ↗
• MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHEN HE WOKE UP, THE INFUSION SET TUBING CAME APART FROM THE QUICK RELEASE. THE BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8530314 ↗