Quick-set® Paradigm® MMT-394 (UDI 05705244006232)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 05705244006232), received between Aug 2, 2017 and Sep 22, 2020 — classified as 3 deaths, 10 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S MOTHER REPORTED THAT HER DAUGHTER'S THE INFUSION SET THAT WAS INSERTED WAS COMPLETELY DISCONNECTED FROM THE CLAMP SITE OF THE TUBING THAT CONNECTS TO BODY. SHE MENTIONED THAT THE TUBING LAID AWAY FROM THE PUMP - ALMOST AS IF IT ONLY SLIPPED OFF. MOREOVER, THE INSULIN WAS MESSED ALL OVER AND HER DAUGHTERS BLOOD GLUCOSE LEVEL WAS VERY HIGH. HOWEVER, THEY MANAGED TO BRING IT DOWN WITH INJECTIONS. FURTHER, IT WAS STATED THAT THE TUBING ENDS WERE NOT BENT OR BROKEN OFF. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10565425 ↗
• InjuryAug 10, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FELL AND EXPERIENCED VOMITING, HIGH BLOOD GLUCOSE LEVEL AND IN AND OUT OF CONSCIOUSNESS. SHE GAVE HERSELF A BOLUS AND AT ONE TIME THE INSULIN JUST LEAKED OUT OF THE SITE, AND HER BLOOD GLUCOSE LEVEL WAS POSSIBLY IN THE RANGE OF 500S MG/DL. FURTHER, WHEN THE INFUSION SET WAS REMOVED IT WAS FOUND TO BE BENT. THEREFORE, SHE CHANGED HER INFUSION SET FOUR TIMES. SHE THOUGHT SHE WOULD BE FINE IN THE MORNING, BUT SHE WAS NOT. THE PATIENT'S HUSBAND THOUGHT SHE HAD THE FLU UNTIL SHE STARTED TALKING TO HER DEAD MOTHER AND HE KNEW SOMETHING WAS WRONG. HE COULD NOT GET HER TO COME THROUGH. THE PATIENT VOMITED THAT SHE TORE HOLES IN HER ESOPHAGUS. SUBSEQUENTLY, THE PATIENT'S HUSBAND CALLED THE AMBULANCE AND TOOK HER TO THE HOSPITAL. ON (B)(6) 2016 AROUND 11:00 AM, SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO BLOOD GLUCOSE LEVEL OF 1000 MG/DL, DIABETIC KETOACIDOSIS WHICH CAUSED ACIDOSIS, HEART ATTACK, AND ORGAN FAILURE. SHE STAYED IN THE INTENSIVE CARE UNIT FOR TWO DAYS AND WAS UNCONSCIOUS, BUT HER BLOOD GLUCOSE LEVEL WAS BROUGHT DOWN SLOWLY. IT WAS STATED THAT WHEN SHE FELL, SHE HAD A

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10383955 ↗
• InjuryAug 10, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL DUE TO ISSUES WITH THE TUBING AND BEEN TRYING TO BOLUS. THEREFORE, THE PATIENT TRIED TO TREAT IT WITH SYRINGE, BUT THE PATIENT WAS ADMITTED TO THE HOSPITAL TWO TIMES. THE FIRST-TIME, PATIENT WAS HOSPITALIZED ON (B)(6) 2020, WITH BLOOD GLUCOSE LEVEL OF 540 MG/DL AND ON (B)(6) 2020, THE PATIENT WAS HOSPITALIZED FOR THE SECOND TIME WITH BLOOD GLUCOSE LEVEL OF 605 MG/DL DUE TO DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE PATIENT RECEIVED INSULIN INTRAVENOUSLY AS CORRECTIVE TREATMENT. FOR FIRST HOSPITALIZATION, THE PATIENT STAYED OVERNIGHT IN THE HOSPITAL AND NEXT DAY, ON (B)(6) 2020, THE PATIENT WAS RELEASED AND FOR SECOND HOSPITALIZATION, THE PATIENT WAS RELEASED ON (B)(6) 2020. MOREOVER, THE PATIENT FACED INSULIN FLOW BLOCK WITH FOUR SETS, BUT DID NOT GET INSULIN FLOW BLOCK ON THE SET THAT HE USED RECENTLY. LATER, IT WAS FOUND THAT THE CANNULA WAS BENT. 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. FUR

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10383875 ↗
• InjuryMar 31, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4).EVENT OCCURRED IN THE UNITED STATES.THE PATIENT REPORTED THAT HE FACED A BENT CANNULA ISSUE AND THE INFUSION SET BEING STUCK INSIDE OF THE SERTER WALLS, SO INSULIN DID NOT FLOW. REPORTEDLY, THE INSIDE WALLS CAUSED INFUSION SET TO STICK TO IT. IT WAS ALSO STATED BY THE PATIENT THAT THE SERTER DID NOT SHOW SIGNS OF PHYSICAL/COSMETIC DAMAGE. MOREOVER, HE CLEANED THE SERTER AFTER EVERY 3-4 USES. FURTHER, WHILE HE INSERTED THE INFUSION SET (NEEDLE- BLUE PLUNGER) IN, IT STUCK INSIDE THE SERTER, BUT HE AND HIS WIFE THOUGHT IT WAS IN THERE. SUBSEQUENTLY, ON (B)(6) 2020 AT 3:00 PM, HE WAS ADMITTED IN THE HOSPITAL AS HIS BLOOD GLUCOSE LEVEL WAS OVER 1200 MG/DL AND HE EXPERIENCED DIABETIC KETOACIDOSIS. MOREOVER, THE INFUSION SET WAS LAST CHANGED ON (B)(6) 2020 AT THE NIGHTTIME. DURING HOSPITALIZATION, HE RECEIVED A DRIP INTRAVENOUSLY, AS HE HAD A INTRAVENOUS PORT ON HIS CHEST THAT'S HOW THEY GAVE THE INSULIN. ON 15-MAR-2020 AT 5:00 PM, HE WAS RELEASED FROM 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. FURTHER

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9902384 ↗
• MalfunctionAug 30, 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, THE PATIENT REPORTED THAT HER BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL AND WHILE THE PATIENT WAS SLEEPING, HER INFUSION SET'S TUBING CAME APART CLOSE TO THE SITE LOCATION. THE SITE LOCATION WAS AT PATIENT'S RIGHT BUTTOCK AND THE PUMP WAS IN RIGHT POCKET OF HER SHIRT. THE INFUSION HAD BEEN IN USE FOR THREE 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 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: Hyperglycemia

  MAUDE report 8948924 ↗
• MalfunctionAug 1, 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 THERE WERE FIVE INFUSION SETS IN WHICH IT WAS IMPOSSIBLE TO ATTACH THE DRAIN AFTER DETACHMENT FROM THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8849896 ↗
• InjuryJun 14, 2019Material Deformation; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S FATHER REPORTED THAT THE INFUSION SET'S TUBE GOT KINKED A FEW DAYS BEFORE THIS REPORT AND SHE HAD ALSO RECEIVED MULTIPLE MOTOR ERRORS. THE PATIENT CHANGED OUT THE INFUSION SET AND WAS GIVEN INSULIN AND A MANUAL INJECTION TO TREAT HER HIGH BLOOD GLUCOSE LEVEL. THEN, SHE WENT TO SLEEP AND HER PUMP DID NOT GIVING A NO DELIVERY ALARM. THEREAFTER, THE PATIENT WENT INTO DIABETIC KETOACIDOSIS AND HER BLOOD GLUCOSE LEVEL WENT HIGH. IT WAS REPORTED TO BE 400 MG/DL AT THE TIME OF INCIDENT AND THE PATIENT WAS ALSO TESTED POSITIVE FOR KETONES. SHE EXPERIENCED NAUSEA, VOMITING, DIZZINESS AND HAD DIFFICULTY IN BREATHING. THE PATIENT HAD BLOOD GLUCOSE LEVEL AT 380 MG/DL WHEN SHE WAS TAKEN TO THE EMERGENCY ROOM. SUBSEQUENTLY, SHE WAS ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL AT 400 MG/DL. SHE RECEIVED INSULIN DRIPS, MANUAL INJECTION, MAGNESIUM, POTASSIUM AND AN ATTEMPT WAS MADE TO GET HER BACK ON THE PUMP. THE PATIENT HAD STAYED IN THE HOSPITAL FOR NINE DAYS AND WAS STILL THERE AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8698649 ↗
• MalfunctionMay 23, 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 WAY TO THE BOTTOM OF THE CANYON WHILE THE PATIENT WAS HIKING, HIS CONTINUOUS GLUCOSE MONITORING SYSTEM WAS GOING UP WHEN HE NOTICED THAT HIS INFUSION SET'S TUBING HAD DETACHED FROM THE QUICK RELEASE. THE SITE LOCATION WAS PATIENT'S STOMACH AND THE PUMP WAS ON THE OPPOSITE SIDE IN RELATION TO THE SITE. THE INFUSION HAD BEEN IN USE FOR A FEW HOURS AND THE INFUSIONS WERE STORED AT HOME WHERE THERE WAS AIR CONDITIONING. THERE MIGHT HAVE BEEN STRESS OR PULL ON THE TUBING AS HE WAS HIKING BUT THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. REPORTEDLY, THE INFUSION SET'S TUBING HAD DETACHED AGAIN, A DAY BEFORE THIS REPORT, FROM THE CANNULA HOUSING ON HIS BODY AND HIS BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 220 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635043 ↗
• MalfunctionApr 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 FACED ISSUES WITH INFUSION SETS ONCE DURING INSERTION AND ONE WHILE THE PATIENT HAD IT ON. WITH THE FIRST ONE, THE PATIENT INSERTED IT FULLY BUT WHEN THE PATIENT REMOVED THE NEEDLE, THE ENTIRE PIECE CAME OFF AND THE STICKY PART REMAINED ON THE SKIN. EVERYTHING CAME OFF AND DETACHED FROM THE PATCH. THIS HAD HAPPENED IN THE PAST AS WELL. IT JUST APPEARED AS IF WHEN THE NEEDLE CAME OUT, IT TOOK EVERYTHING WITH IT. THEREAFTER, THE PATIENT HAD TO MANUALLY REMOVE THE ADHESIVE. WITH THE SECOND ONE, IT WAS INSERTED FINE BUT ABOUT ONE HOUR AFTER INSERTION, WHILE THE PATIENT WAS REMOVING IT TO TAKE A SHOWER, THE PLASTIC TUBING SEPARATED LIKE IT COMPLETELY BROKE OFF AT THE QUICK RELEASE. THE SITE LOCATION WAS HIGHER PART OF LEFT LEG AND THE PUMP WAS CLIPPED TO THE BELT. THE INFUSIONS WERE STORED IN THE CLOSET AT HOME WITH NO EXTREME TEMPERATURE. 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 8563394 ↗
• InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT'S MOTHER REPORTED THAT TWO INFUSION SETS WERE KINKED WHEN REMOVED FROM PATIENT'S SITE AND INFUSION SET CANNULA WAS CRIMPED. THE PATIENT WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVEL WAS 480 MG/DL AT THE TIME OF HOSPITALIZATION. DURING HOSPITALIZATION, PATIENT WAS TREATED WITH PUMP AND DRIP VIA INTRAVENOUS ROUTE. THE INFUSION SET HAD BEEN IN USE FOR A DAY AND A HALF AND SITE LOCATION WAS AT THE ABDOMEN. THE PATIENT WAS HOSPITALIZED FOR 3 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 8548527 ↗
• InjuryApr 24, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE (B)(6). THE PATIENT HAD A BENT CANNULA DUE TO WHICH SHE CHANGED HER INFUSION SET. SUBSEQUENTLY, SHE BECAME UNWELL WITH HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 28.8 MMOL/L AT THE TIME AND KETONES AT MORE THAN 6 MMOL/L. SHE WAS THEN ADMITTED TO THE HOSPITAL DUE TO HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS WHILE SHE WAS STILL CONNECTED TO THE PUMP. SHE WAS TREATED WITH A SLIDING SCALE AND SALINE DRIP. THE PUMP REMAINED CONNECTED BUT SUSPENDED WHILST CUSTOMER WAS IN THE HOSPITAL. THE PATIENT ENDED UP REMOVING THE CANNULA ON APPROXIMATELY THE SECOND DAY OF BEING IN HOSPITAL AND FOUND THAT THE CANNULA WAS CLEARLY BENT. THE NIGHT BEFORE BEING DISCHARGED, THE PATIENT WAS STARTED BACK ON THE PUMP WITH A WHOLE NEW SET/RESERVOIR AND INSULIN. THE PATIENT REPORTED THAT WHEN SHE USED THE OLDER BLUE SERTER, SHE SEEMED TO GET BENT CANNULAS AND IF SHE USED THE NEW GREY/GREEN SERTER THEN THE SET INSERTED FINE. IT WAS FOUND THAT SHE HAD SCARRED, HARDENED LUMPS AND WAS OVERWEIGHT. THE PATIENT WAS RELEASE FROM THE HOSPITAL AFTER THREE DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING IS

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8543378 ↗
• InjuryApr 18, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SHE HAD A BENT CANNULA AT NINETY-DEGREE ANGLE, SO SHE REMOVED THE CANNULA AND SELF-TREATED HERSELF WITH AN INJECTION, BUT HER SUGAR STILL DID NOT LOWER DOWN THEREFORE SHE WENT TO THE HOSPITAL. THE SITE LOCATION WAS AT THE HIP/TOWARDS THE BACK AND THE ISSUE OCCURRED ON THE FIRST DAY OF USING INFUSION SET. THE PATIENT WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL AT THE TIME OF HOSPITALIZATION AND DIABETES KETOACIDOSIS. SHE RECEIVED TREATMENT VIA INTRAVENOUS ROUTE. ACCORDING TO THE DOCTOR THE PATIENT WAS MEDICALLY FINE BUT DID NOT WANTED HER TO BE RELEASED. SHE WAS HOSPITALIZED FOR TWO DAYS AND WAS STILL IN THE HOSPITAL AT THE TIME OF REPORTING. 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 8526697 ↗
• InjuryApr 16, 2019Leak/Splash; Leak/Splash

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT HAD LEAKAGE FROM THE INFUSION SET TUBING AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT HAD HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS. THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT AND WAS DOWNGRADED FROM THERE TO THE MEDICINE SURGERY FLOOR, IN A REGULAR ROOM. THE PATIENT NOTICED CRACKS OR SPLITS IN THE TUBING ALONG THE RESERVOIR. THE PATIENT WAS HOSPITALIZED FOR TWO DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517523 ↗
• InjuryApr 16, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED BY THE PATIENT'S WIFE, THAT FOUR WEEKS AGO, HER HUSBAND HAD EXPERIENCED AN ISSUE WITH THE INFUSION SET IN THE FORM OF BENT CANNULA. THE PATIENT WAS SICK AND THOUGHT THAT HE HAD FLU. MOREOVER, HIS HEART WAS IN DISTRESS, HIS HANDS WERE SHAKING AND HAD VOMITING AND NAUSEA. REPORTEDLY THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS WHICH WAS TREATED WITH 30 UNITS OF INSULIN, MANUAL INJECTION BY HIS WIFE. ANOTHER 15 UNITS WERE GIVEN LATER. THE PATIENT WENT TO THE BATHROOM AND FELL ON THE GROUND, SO EMERGENCY MEDICAL SERVICES WERE CALLED, AND HE WAS TAKEN TO THE EMERGENCY ROOM. THE PATIENT'S BLOOD GLUCOSE WENT UP TO 740 MG/DL AND HE EXPERIENCED DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THEY TOOK THE CANNULA OFF AND NOTICED THAT IT WAS CRIMPED. THEY HAD TO DO A HEART CATHETERIZATION ON HIM BECAUSE TROPONIN (HEART ENZYMES) WAS VERY HIGH. THE PATIENT WAS IN THE INTENSIVE CARE UNIT FOR THREE DAYS. HE WAS HOSPITALIZED FOR FOUR DAYS AND WAS TREATED WITH SOME UNSPECIFIED DRUGS VIA THE INTRAVENOUS ROUTE, HEART CATHETERIZATION AND ELECTROLYTES. SHE ALSO REPORTED THAT HER HUSBAND CHANGED THE SET TWICE A WEEK. T

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8517248 ↗
• MalfunctionMar 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE (B)(6). THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DISCONNECTED FROM THE SITE WHERE THE INFUSION SET CONNECTS TO THE BODY. UPON INVESTIGATION, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8463117 ↗
• 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'S MOTHER REPORTED THAT THE TUBING HAD DETACHED FROM THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8457689 ↗
• MalfunctionMar 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  INITIALLY, THE CASE WAS SUBMITTED ON 22-MAR-2019. HOWEVER, UPON RECEIPT OF FOLLOW UP INFORMATION OF COMPLAINT INVESTIGATION, ALL THE TEST RESULTS WERE WITHIN SPECIFICATIONS, THEREFORE THE INFUSION SET CANNOT BE RELATED TO THE REPORTED EVENT. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HER SET KEPT COMING OFF AS THE SITE WAS DISCONNECTED FROM HER (CANNULA) AT THE QUICK RELEASE WHILE SLEEPING, THIS ISSUE OCCURRED NUMEROUS TIMES AND THOUGHT IT WAS HER FAULT. IN THE MORNING OF THIS REPORT, THIS ISSUE OCCURRED AGAIN, AND HER BLOOD GLUCOSE LEVEL WAS 396 MG/DL. THIS ISSUE OCCURRED WITH THE SAME LOT (5 BOXES) A DOZEN TIMES. THE SITE LOCATION WAS AT THE THIGH BECAUSE THE ABDOMEN DOES NOT WORK WELL FOR HER (HARDEN TISSUE) AND THE PUMP WAS ON HER WAIST INSIDE A FANNY PACK. THE INFUSION WAS IN USE FOR HALF A DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN HER BOXES IN HER HALLWAY. 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 8443202 ↗
• MalfunctionFeb 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 HAVING ISSUES WITH THE RESERVOIR AND QUICK SET. WHILE CHANGING THE INFUSION SET, SHE NOTICED THAT THE TUBING WAS BENT AT THE END AND WHEN SHE INSERTED, IT HURT. SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH SHE WAS ABLE TO TREAT. PRIOR TO THE EVENT, SHE WAS SIMPLY WALKING AROUND THE HOUSE. THE SITE LOCATION WAS HER LEG AND THE PUMP WAS WORN ON HER WAIST. 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 HER BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8338280 ↗
• MalfunctionFeb 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT WHILE SLEEPING, HER INFUSION SET'S TUBING CAME APART CLOSE TO THE SITE AT QUICK RELEASE. THERE WERE DIFFERENT SITES LIKE UPPER BUTTOCK AND LOWER BACK MOSTLY. THE PUMP WAS IN THE BACK POCKET OR BACK OF THE PANTS. THE INFUSION WAS USED FOR JUST A DAY OR TWO. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. 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: No Known Impact Or Consequence To Patient

  MAUDE report 8338247 ↗
• MalfunctionFeb 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 TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN OUT OF THE TUBING ABOUT HALF AN HOUR AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH 3 SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8314531 ↗
• MalfunctionFeb 1, 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 THE TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN OUT OF TUBING ABOUT 24 HOURS AFTER CHANGING THE SET. THIS ISSUE OCCURRED WITH 3 SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8296036 ↗
• MalfunctionJan 21, 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 LYING DOWN, CANNULA DID NOT STAY CONNECTED TO QUICK RELEASE ON THE CATHETERS IN THE BODY. THIS WAS THE SECOND TIME THE SAME ISSUE HAD HAPPENED, AND HE HAD PROBLEMS WITH VARIOUS CANNULAS OVER THE LAST WEEK AND WEEKEND. HE HAD LOST 8 CANNULAS WITH THIS ISSUE AND HAD 2 OTHER BOXES FROM THE SAME LOT OF INFUSION SET. THE SITE WAS AT THE UPPER BOTTOM AND THE PUMP WAS AT THE WAIST. THE INFUSION WAS IN USE FOR 1 OR 2 DAYS. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PATIENT STATED THAT WITHOUT NOTICING ONE OF THE TUBING WAS PULLED 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 8265872 ↗
• InjuryJan 21, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED ISSUES WITH BENT CANNULA. SHE WAS ADMITTED TO THE HOSPITAL AND WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS. REPORTEDLY, THE BLOOD GLUCOSE WAS 529 MG/DL, AS THE PUMP DID NOT DETECT KINK ON THE CANNULA. THE PATIENT WAS HOSPITALIZED FOR 3 DAYS. SHE ALSO REPORTED KINKED CANNULA ON 3 OTHER INFUSION SETS THAT SHE HAD REPLACED. 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 8264557 ↗
• MalfunctionJan 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'S FATHER REPORTED THAT FOUR OF THEIR INFUSION SETS TUBING GOT DISCONNECTED AT PORT ENDS NEAR INFUSION SET INSERTION SITES AND THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL DUE TO OVERNIGHT FAILURES OF INFUSION SET. REPORTEDLY, THE PATIENT CHANGES THE INFUSION SET AFTER EVERY 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8255979 ↗
• MalfunctionJan 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT SET WOULD NOT RECONNECT AT THE QUICK RELEASE AND ALSO A SET THAT CAME OFF HER BODY WHILE SHE WAS SLEEPING. THE SITE LOCATION WAS RIGHT SIDE BELLY AND THE PUMP WAS WORN ON BELT ON THE SAME SIDE OF HER WAIST. ONCE, SHE DISCONNECTED TO TAKE SHOWER AND THERE WAS NO ISSUES UNTIL SHE ATTEMPTED TO RECONNECT AS SHE WAS UNABLE TO RECONNECT. ANOTHER TIME WHEN THE DETACHMENT OCCURRED WHILE SLEEPING, HER BLOOD GLUCOSE LEVEL WAS 536 MG/DL WHICH WAS TREATED USING PUMP. REPORTEDLY, WHEN SHE WOKE UP THE ADHESIVES WERE NOT STICKING TO HER AND THE SET PULLED OUT. THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE INFUSION HAD BEEN IN USE MIGHT BE ONE DAY. ALSO, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WASN'T DROPPED WITH THE SET CONNECTED TO THE BODY. THE LOCATION OF DETACHMENT WAS AT QUICK RELEASE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8238900 ↗