Quick-set® Paradigm® MMT-386Recalls & reported problems

Summary

The FDA's MAUDE database contains 95 adverse event reports that list this exact device (DI 05705244006577), received between Apr 12, 2018 and Nov 21, 2024 — classified as 1 death, 6 injuries, 88 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (87 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 95 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4) EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET WAS LEAKING EVENT ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754923 ↗
• MalfunctionAug 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ROMANIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA FRACTURE EVENT ON 09-JUL-2024 WHICH CAUSED BLEEDING. THE SET WAS IN USE FOR 2 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19951299 ↗
• MalfunctionJan 27, 2021Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED THAT, THE INFUSION SET'S CORD/TUBING WAS BROKEN 7 INCHES FROM WHERE IT CONNECTS CLOSER TO THE SITE, WHILE SHE WAS SITTING IN THE COUCH. SHE PUT IT THIS MORNING AND WHEN SHE LOOKED DOWN, IT WAS OBSERVED THAT BOTH THE PIECES LANDED ON THE COUCH. THE SITE LOCATION WAS PATIENT'S LEFT ABDOMEN AND THE PUMP WAS IN HER LEFT 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. FURTHER, THERE WAS STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11241534 ↗
• MalfunctionOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED BY THE PATIENT THAT THE INFUSION SET'S LEAKED AT THE QUICK RELEASE, ALTHOUGH THE QUICK RELEASE WAS TIGHTLY CONNECTED. IT WAS NOTICED WHEN THERE WAS A SMELL OF INSULIN AND IT HAPPENED WITH FOUR INFUSION SETS. THE INFUSION SET HAD BEEN USED FOR 2-3 DAYS AND THERE WAS NO STRESS OR PULL ON THE INFUSION SET TUBING. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING), IT SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10688624 ↗
• MalfunctionMay 12, 2020Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT HAD INSERTED THE INFUSION SET IN THE MORNING AND DURING THE NIGHT THE CATHETER CAME LOOSE AT THE SITE OF THE QUICK RELEASE, BUT NOT THE QUICK RELEASE ITSELF. FURTHER, THIS RESULTED IN HIGH BLOOD GLUCOSE LEVEL OF 28 MMOL/L, IN THE MORNING OF (B)(6) 2020. MOREOVER, ON (B)(6) 2020, AT 16:32:59 HOURS (AT THE MOMENT OF THIS REPORT), HIS BLOOD GLUCOSE LEVEL WAS REDUCED TO 05 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 10046230 ↗
• MalfunctionFeb 24, 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 HAD DETACHED CLOSE TO THE SITE LOCATION WHILE HAVING DINNER. THE SITE LOCATION WAS ON THE RIGHT SIDE OF THE PATIENT'S THIGH AND THE PUMP WAS IN THE SIDE POCKET. THE INFUSION HAD BEEN USED FOR 2 HOURS AND THEY WERE STORED IN THE ROOM. REPORTEDLY, 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 9743427 ↗
• MalfunctionFeb 11, 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 WHILE THE PATIENT WAS WALKING TO THE KITCHEN, HER DAUGHTER NOTICED THAT SOMETHING WAS HANGING, THOUGH EARLIER, THE PATIENT WENT OUT TO BUY SOME FOOD AND IT MAY HAVE BEEN CAUGHT/GOT STUCK. REPORTEDLY, THE INFUSION SET'S TUBING WAS DETACHED AT THE SITE. THE SITE LOCATION WAS AT PATIENT'S RIGHT SIDE AND THE PUMP WAS IN HER RIGHT POCKET. MOREOVER, THE INFUSION HAD BEEN IN USE FOR THE SECOND DAY. THE INFUSIONS WERE NOT 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 AS THE PATIENT STATED THAT IT MAY HAVE BEEN 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 9691424 ↗
• InjuryFeb 4, 2020Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT WHILE THE PATIENT WAS BUSY DOING A LOT OF THINGS AND HAD A BANQUET TO GO TO, SHE FELT SICK AS HER BLOOD GLUCOSE LEVEL RAISED, THEREFORE HER DAUGHTER TOOK HER TO THE EMERGENCY ROOM. SUBSEQUENTLY ON (B)(6) 2019, THEY TRANSPORTED HER TO THE HOSPITAL BY AN AMBULANCE AND AT 09:00 PM, SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVEL OF 1006 MG/DL. WHILE IN THE HOSPITAL, THEY CHECKED HER SITE AND IT WAS BENT DUE TO WHICH SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. REPORTEDLY, THE PATIENT HAD A LIVER TRANSPLANT AND SHE WAS ON AN ANTI-REJECTION MEDICATION THAT DOES AFFECT HER MEMORY WHEN SOMETHING WAS TOLD BUT MAY NOT REMEMBER WHAT TO DO. DURING HOSPITALIZATION, SHE RECEIVED INSULIN VIA INTRAVENOUS ROUTE AS CORRECTIVE TREATMENT. ON (B)(6) 2019, SHE WAS RELEASED FROM THE HOSPITAL. ON THE DAY OF THIS REPORT ((B)(6) 2020), SHE ONLY HAD COFFEE AND HER BLOOD GLUCOSE LEVEL WAS 364 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

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9669200 ↗
• MalfunctionJan 29, 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, ON (B)(6) 2019, THE PATIENT'S INFUSION SET'S TUBING BECAME SEPARATED FROM THE QUICK-SET CONNECTOR, CLOSE TO THE SITE LOCATION AS THE GLUE CAME UNDONE FROM THE O RING, WHILE SLEEPING. THIS ISSUE OCCURRED FOR THE 4TH TIME, EVERY SIXTH MONTH OR SO. REPORTEDLY, SHE WOKE UP WITH BLOOD GLUCOSE LEVEL OF 389 MG/DL AND DIABETIC KETOACIDOSIS DUE TO THIS ISSUE. FURTHER, THE SITE LOCATION WAS AT HER RIGHT UPPER BUTTOCK AND THE PUMP WAS IN THE BED. THE INFUSION HAD BEEN USED FOR THE SECOND DAY. MOREOVER, 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9640446 ↗
• MalfunctionDec 24, 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'S TUBING DETACHED ITSELF, WHILE SLEEPING. MOREOVER, THE PATIENT HAD POSITIVE RESULTS IN KETONES TEST, NAUSEA, VOMITING AND THE BLOOD GLUCOSE LEVEL WAS 23 MMOL/L AT THE TIME OF THIS EVENT. FURTHER, ON (B)(6) 2019, THE PATIENT CHANGED THE INFUSION SET. REPORTEDLY, THE LAST NIGHT FROM THE DAY OF THIS REPORT ((B)(6) 2019), PATIENT'S BLOOD GLUCOSE LEVEL WAS HIGH. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9514805 ↗
• MalfunctionNov 27, 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 PATIENT'S INFUSION SET'S TUBING HAS SEPARATED FROM THE QUICK SET CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9382464 ↗
• 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. IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH THE TUBING THREE DAYS AGO FROM THE DAY OF THIS REPORT ((B)(6) 2019), AS THE INFUSION SET'S TUBING DISCONNECTED FROM THE QUICK RELEASE AT THE SITE WHILE SLEEPING. THE PATIENT WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL. THE SITE LOCATION WAS AT PATIENT'S UPPER BUTTOCK AND THE PUMP WAS LOCATED ON TOP OF THE DRESS. THE INFUSION HAD BEEN IN USE FOR 2 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 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: No Known Impact Or Consequence To Patient

  MAUDE report 9294315 ↗
• MalfunctionOct 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 THE INFUSION SET'S TUBING HAD DETACHED FROM THE QUICK RELEASE AND IT WAS NOTICED WHEN THE PATIENT WOKE UP. THE SITE LOCATION WAS LEFT SIDE OF THE PATIENT'S ABDOMEN AND THE PUMP WAS CLIPPED TO THE SHIRT COLLAR. THE INFUSION WAS BEING USED FOR ONE DAY AND THEY WERE STORED WERE STORED IN A BOX, THEY COME IN A KITCHEN CABINET. FURTHER, 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: No Known Impact Or Consequence To Patient

  MAUDE report 9236765 ↗
• MalfunctionOct 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. THE PATIENT REPORTED THAT IN THE MORNING OF (B)(6) 2019, WHEN SHE WOKE UP, THE LINE WAS CUT OFF FROM THE BODY AT THE QUICK RELEASE. THE SITE LOCATION WAS HER LOWER LEFT AND RIGHT STOMACH. THE PUMP WAS LOCATED ON THE RIGHT SIDE OF HER BED. THE INFUSION HAD BEEN IN USE FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN A BOX IN THE CLOSET AND A FREEZER BAG IN THE BEDROOM. SHE WAS UNSURE IF THERE WAS ANY 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 USE DEVICE (1 TUBING), 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 9232590 ↗
• 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'S HUSBAND REPORTED THAT HIS WIFE'S INFUSION SET'S TUBING GOT DETACHED FROM THE QUICK RELEASE. THE SITE LOCATION WAS AT THE PATIENT'S ABDOMEN AND THE PUMP WAS WORN ON THE SAME SIDE IN RELATION TO THE SITE. 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 PERFORMED ON THE RETURNED USED DEVICE (2 TUBING'S), IT WAS FOUND THAT THE TUBING'S WERE DETACHED FROM THE TUBING CONNECTORS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9232392 ↗
• MalfunctionSep 20, 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'S TUBING DETACHED FROM THE QUICK RELEASE. THIS ISSUE HAPPENED WITH FOUR INFUSION SETS FROM THE SAME BOX. REPORTEDLY, ONCE THIS EVENT HAPPENED AT NIGHT AND THE PATIENT WOKE UP WITH BLOOD GLUCOSE LEVEL OF 27 MMOL/L. THE SITE LOCATIONS WERE THE PATIENT'S ABDOMEN, LEG AND ARM. THE BLOOD GLUCOSE WAS NOW REPORTED TO BE 6.5 MMOL/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 9096391 ↗
• 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 DETACHED AT THE QUICK RELEASE AND THE PATIENT NOTICED INSULIN OUT OF THE TUBING. THIS ISSUE OCCURRED WITH A COUPLE OF SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8953470 ↗
• MalfunctionAug 23, 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 05-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 INSERTED SET) SHOWED THAT THE VISUAL TEST RESULTS WERE IN ACCORDANCE WITH SPECIFICATIONS. BASED ON THE RESULT: DEVICE, METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT AT NIGHT, HE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL UP TO 400 MG/DL. SUBSEQUENTLY, HE RECEIVED A BLOCKED ALARM FOR NO INSULIN DELIVERY AND WHEN HE LOOKED AT HIS SET, HE NOTICED THAT THE QUICK RELEASE HAD COME LOOSE, AS IT WAS NOT LOCKED IN PLACE. AT 9:24 P.M., BLOOD GLUCOSE LEVEL WAS 180 MG/DL AND AT 11:29 P.M. IT WAS 248 MG/DL. FURTHERMORE, THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. HE CALCULATED THE CORRECTION OFF THE PUMP AND GAVE HIMSELF A MANUAL INJECTION OF 7 UNITS WHILE HOLDING THE INFUSION SET IN PLACE, WHICH SEEMED TO HAVE WORKED. AT 11:37 P.M., BLOOD GLUCOSE LEVEL WAS AT 247 MG/DL AFTER BOLUS. HE DID NOT THINK TOO MUCH ABOUT IT AND HAD A BIG DINNER. THE SITE LOCATION WAS ON THE LEFT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE LEFT SIDE. REPORTEDLY, THE INFUSION

  Patient problems: Hyperglycemia

  MAUDE report 8924156 ↗
• MalfunctionAug 6, 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 (B)(6) 2019, THE PATIENT WAS SLEEPING WHEN HER BLOOD GLUCOSE LEVEL GOT A LITTLE BIT HIGHER THAN NORMAL. SHE WOKE UP AND NOTICED THAT THE INFUSION SET'S TUBING HAD DETACHED AT THE SITE CONNECTOR CLOSE TO THE SITE LOCATION. THE INFUSION HAD BEEN IN USE FOR TWO DAYS AND THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. REPORTEDLY, THE SITE LOCATION WAS PATIENT'S THIGH AND THE PUMP WAS WORN AROUND HER WAIST ON THE SAME SIDE AS THE INFUSION SET. 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 8862976 ↗
• MalfunctionAug 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (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, UNKNOWN HOURS AFTER SET CHANGE. THIS ISSUE OCCURRED WITH TWO-THREE SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8849829 ↗
• MalfunctionJul 19, 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 HAD HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 277 MG/DL (2.77 G/L) AND THERE WAS A DETACHMENT BETWEEN INFUSION SET'S TUBING AND THE CATHETER. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8806225 ↗
• InjuryJul 12, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEHYDRATION, VOMITING AND HIGH BLOOD GLUCOSE LEVEL, WHICH THE PATIENT TRIED TO SELF-TREAT BY MANUALLY INJECTING 20 UNITS OF UNSPECIFIED MEDICATION. ON (B)(6) 2019, THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY, ADMITTED TO THE HOSPITAL WITH BLOOD GLUCOSE LEVEL AT 481 MG/DL. WHEN THE SITE WAS REMOVED, IT WAS FOUND THAT THE CANNULA WAS BENT. AS CORRECTIVE TREATMENT, THE PATIENT RECEIVED INSULIN VIA INTRAVENOUS ROUTE AND TREATMENT FOR DEHYDRATION. ON (B)(6)2019, THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH BLOOD GLUCOSE LEVEL AROUND 300 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 WAS AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8783901 ↗
• MalfunctionJul 4, 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 PATIENT WAS GETTING READY TO GO TO BED WHEN IT WAS NOTICED THAT THE INFUSION SET WAS NOT STAYING ATTACHED. WHILE THE PATIENT WAS SLEEPING, THE INFUSION SET CAME APART AT THE TUBING CONNECTOR. THE SITE LOCATION WAS PATIENT'S RIGHT ABDOMEN AND THE PUMP WAS IN THE PATIENT'S RIGHT POCKET. THE INFUSION HAD BEEN IN USE FOR LESS THAN A DAY AND THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. REPORTEDLY, 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 WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8762213 ↗
• MalfunctionJun 21, 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 OFF FROM WHERE IT WAS CONNECTED TO THE QUICK RELEASE OVER NIGHT WHILE THE PATIENT WAS SLEEPING. THE PATIENT WOKE UP WITH BLOOD GLUCOSE LEVEL AT 267 MG/DL. THE SITE LOCATION WAS RIGHT SIDE OF ABDOMEN AND THE PUMP WAS ALSO ON THE RIGHT SIDE. THE INFUSION HAD BEEN IN USE FOR ONE AND A HALF DAYS. 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 IF THERE WAS 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 DEVICE, IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8721234 ↗
• InjuryJun 10, 2019Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT HIS BLOOD GLUCOSE LEVEL WAS AT 409 MG/DL WHILE HE WAS SETTING THE INFUSION SET TO ADMINISTER INSULIN. THE INFUSION SET WAS INSERTED INTO HIS STOMACH. HOWEVER, INSULIN WAS NOT GOING INTO HIS SYSTEM. THEREAFTER, HE WENT TO THE EMERGENCY ROOM WITH HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 541 MG/DL AND DIABETIC KETOACIDOSIS. UPON ARRIVING AT THE HOSPITAL, THE CANNULA WAS FOUND TO BE BENT. THEY TOOK IT OUT AND CHANGED IT. THE INFUSION SET HAD BEEN IN USE FOR TWO DAYS. THE PATIENT STAYED IN THE HOSPITAL FOR MORE THAN ONE DAY AND WAS STILL THERE 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 8682171 ↗