Silhouette® Paradigm® MMT-378Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05705244008755), received between Dec 12, 2017 and Jun 12, 2026 — classified as 1 death, 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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 18, 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.

• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS PASSED AWAY DUE TO AN UNKNOWN REASON ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25482683 ↗
• MalfunctionJan 19, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS TUBING DETACHMENT EVENTS ON (B)(6) 2025. THE PATIENT REPORTED THAT INFUSION SET WAS JUST USED IT TODAY BUT THE INFUSION SET ARE OLD ONES WHICH ARE AROUND 5 YEARS. THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112331 ↗
• MalfunctionJan 19, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS TUBING DETACHMENT EVENTS ON (B)(6) 2025. THE PATIENT REPORTED THAT INFUSION SET WAS JUST USED IT TODAY BUT THE INFUSION SET ARE OLD ONES WHICH ARE AROUND 5 YEARS. THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112325 ↗
• MalfunctionJan 19, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS TUBING DETACHMENT EVENTS ON (B)(6) 2025.THE PATIENT REPORTED THAT INFUSION SET WAS JUST USED IT TODAY BUT THE INFUSION SET ARE OLD ONES WHICH ARE AROUND 5 YEARS.THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112324 ↗
• MalfunctionJan 19, 2026Detachment of Device or Device Component

  REFERENCE NUMBER (B)(4). EVENT OCCURED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS TUBING DETACHMENT EVENTS ON (B)(6) 2025. THE PATIENT REPORTED THAT INFUSION SET WAS JUST USED IT TODAY BUT THE INFUSION SET ARE OLD ONES WHICH ARE AROUND 5 YEARS. THE INSERTION SITE WAS ABDOMEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24112321 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYERGLYCEMIA, DEHYDRATION, AND VOMITING EVENT. BLOOD GLUCOSE LEVEL WAS 960 MG/DL AT THE TIME OF THE EVENT. PATIENT WAS EXPERIENCED THE SYMPTOMS OF SICK/UNWELL. PATIENT GOT TREATED WITH INSULIN VIA INTRAVENOUS (IV). THE DURATION OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 22181730 ↗
• InjuryMar 2, 2022Material Twisted/Bent; Material Twisted/Bent

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT EXPERIENCED NAUSEA, VOMITING, NOT FEELING GOOD, THIRSTY, HAD HIGH BLOOD GLUCOSE LEVELS DUE TO A BENT CANNULA. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN. CONSEQUENTLY, ON (B)(6) 2022 AT 15:00 HOURS THE PATIENT WAS ADMITTED TO THE HOSPITAL AS THE BLOOD GLUCOSE LEVEL WAS ABOVE 600 MG/DL AND EXPERIENCED DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE PATIENT RECEIVED INSULIN DRIP INTRAVENOUSLY. REPORTEDLY, ON THE DAY OF THIS REPORT (22-FEB-2022), THE PATIENT WAS STILL IN THE HOSPITAL AND WAS ADMITTED IN THE INTENSIVE CARE UNIT. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 355 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 13648810 ↗
• MalfunctionOct 1, 2021Detachment 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) 2021, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET LEAKED AT THE TUBING AS IT CAME APART. 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12559449 ↗
• MalfunctionMay 28, 2021Detachment 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) 2021, IT WAS REPORTED THAT AS THE PATIENT LOOKED DOWN, THE INFUSIONS SET'S TUBING CAME OUT OF THE CAP DURING PATIENT'S NORMAL ROUTINE. THIS ISSUE OCCURRED FOR THE THIRD TIME. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED TO THE RIGHT SIDE IN RELATION TO THE SITE. MOREOVER, THE INFUSION HAD BEEN USED FOR THE SECOND DAY. REPORTEDLY, 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 PATIENT'S BODY. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 278 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11899845 ↗
• MalfunctionMay 10, 2021Detachment 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) 2021, IT WAS REPORTED THAT WHILE THE PATIENT WAS WATCHING TELEVISION, HE NOTICED THAT THE INFUSION SET HAD DETACHED FROM THE TUBING CONNECTOR WHILE SLEEPING. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS ON THE LEFT SIDE IN RELATION TO THE SITE. MOREOVER, THE INFUSION HAD BEEN USED FOR ONE DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN THE BATHROOM AND HAD A LITTLE OF HUMIDITY. THERE WAS NO STRESS OF PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. CURRENTLY, HIS BLOOD GLUCOSE LEVEL WAS 320 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11795790 ↗
• MalfunctionJan 27, 2021Detachment 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 HAD DISCONNECTED AT THE QUICK RELEASE/ SITE CONNECTOR WHILE SITTING. THE SITE LOCATION WAS LEFT SIDE OF THE PATIENT'S ABDOMEN AND THE PUMP LOCATED AT THE RIGHT SIDE. THE INFUSION SET HAD BEEN USED FOR THE FIRST DAY. MOREOVER, THE INFUSION SETS 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. CURRENTLY, THE PATIENT BLOOD GLUCOSE LEVEL WAS 342 MG/DL. UPON VISUAL INSPECTION, ON THE RETURNED USED DEVICE (11 TUBING), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE PCC LOCK CONNECTOR ON 9 OF 11 SAMPLES THE REST OF THE SAMPLES WERE DETACHED FROM THE PCC AND TUBING-CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11238034 ↗
• MalfunctionSep 7, 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 PATIENT'S INFUSION SET'S PLASTIC TUBING TOTALLY DETACHED FROM THE NEEDLE AT THE TUBING CONNECTOR DURING AN OUTDOOR EVENT-WORKING AND HE HAD NO IDEA WHY IT DETACHED. PATIENT'S BLOOD GLUCOSE LEVEL WAS 300 MG/DL THE SITE LOCATION WAS HIS ABDOMEN AND THE PUMP WAS LOCATED RIGHT UNDER HIS CLOTHES AND THE SET IS 5-6 INCHES NEAR TO PUMP. MOREOVER, THE INFUSION HAD BEEN USED FOR THE SECOND DAY. 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: Hyperglycemia

  MAUDE report 10498520 ↗
• MalfunctionMay 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT UPON OPENING THE PACKAGE INFUSION SET'S TUBING WAS ALREADY DETACHED AT THE TUBING CONNECTOR. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS ALSO LOCATED ON THE ABDOMEN. REPORTEDLY, THE INFUSIONS WERE KEPT IN THE CABINET. 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 10068795 ↗
• MalfunctionNov 26, 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 TUBING CONNECTOR, WHILE PERFORMING NORMAL DAILY ACTIVITY/NO EXTRACURRICULAR. THE SITE LOCATION WAS AROUND THE PATIENT'S HIPS AND THE PUMP WAS LOCATED ON THE BELT. THIS ISSUE HAPPENED FOR THE FIRST TIME. REPORTEDLY, THE BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 400 MG/DL BUT THE PATIENT FELT FINE. THE INFUSIONS WERE STORED IN THE BEDROOM. 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 9374557 ↗
• MalfunctionNov 22, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE. FURTHER, THE SITE LOCATION WAS HER ABDOMEN AND THE PUMP WAS ALSO LOCATED ON HER ABDOMEN. THE INFUSION HAD BEEN USED FOR ONE DAY. THERE WAS STRESS OR PULL ON THE TUBING BECAUSE OF THE 'SMART VEST: AIRWAY CLEARANCE SYSTEM' AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. REPORTEDLY, HER VEST EFFECTED THE INSERTION SITE AND IT SEEMED TO PULL OUT THE CANNULA OUT OF HER SKIN, WHEN SHE STARTED USING THE VEST. REPORTEDLY, SHE WAS USING A 'SMART VEST: AIRWAY CLEARANCE SYSTEM' A THERAPY THAT COULD HELP HER BREATH BETTER. MOREOVER, IT WAS STATED THAT SHE HAD USED HER THIGH AS THE SITE LOCATION, BUT IT DID NOT WORK BECAUSE IT ALWAYS FELL OFF. FURTHER, SHE HAD WASTED TOO MUCH INFUSION SETS AND IT ALWAYS FELL OFF/DISLODGE WHILE USING THE SMART VEST. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9361761 ↗
• MalfunctionNov 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT WHILE THE PATIENT WAS AT HIS MOTHER'S HOUSE, SITTING ON THE SOFA AND WHEN WAS LEAVING, HE NOTICED THAT THE INFUSION SET'S TUBING WAS HANGING, AS IT CAME OUT OF THE PLASTIC CLEAR CONNECTOR CAP. THIS ISSUE OCCURRED WITH TWO INFUSION SETS. THE SITE LOCATION WAS AT RIGHT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS WORN ON THE RIGHT BELT LOOP. ONE INFUSION SET MIGHT HAD BEEN IN USE FOR A DAY AND OTHER MIGHT HAD BEEN LASTED FOR A DAY. REPORTEDLY, THE INFUSIONS WERE STORED ON A TABLE IN A DRAW AND ONE BOX ON TOP OF THE TABLE AT ROOM TEMPERATURE. 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 RETURNED USED DEVICE (8 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 9265208 ↗
• MalfunctionOct 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 28-NOV-2019: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING) 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 SHE EXPERIENCED BROKEN LINES AS THE TUBING SNAPS OFF AT THE SITE. REPORTEDLY, THE TUBING STARTED TO SEPARATE AT THE TUBING CONNECTOR. THE SITE LOCATION WAS HER ABDOMEN AND THE PUMP WAS CLIPPED ON THE PANTS. THE INFUSION HAD BEEN IN USE FOR WITHIN A DAY AND THEY 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. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9184240 ↗
• MalfunctionApr 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED THAT THE INFUSION SET CAME APART FROM BOTH THE INSERTION SITE AND TUBING CONNECTOR WHILE SLEEPING. THE SITE LOCATION WAS AT THE RIGHT ABDOMEN AND THE PUMP WAS CONNECTED TO THE PANTS. 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. 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 8559965 ↗
• MalfunctionApr 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 THE TUBING FROM HER SET CAME OFF HER TUBING CAP AT THE TUBING CONNECTOR WHILE SHE WAS PICKING UP THE PUMP TO REPLACE BATTERY AND IT CAME OFF. THE TUBING LOOKED A LITTLE KINKED EARLIER. THE SITE LOCATION WAS AT THE RIGHT ABDOMEN AND THE PUMP WAS LAYING ON THE DESK. THE INFUSION HAD BEEN IN USE FOR THE 2ND DAY. REPORTEDLY, THE INFUSIONS WERE STORED IN A SPECIAL DRAWER. 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 PCC/LUER LOCK CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8538812 ↗
• 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 WHILE SLEEPING AT NIGHT, THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE AND SHE WOKE UP WITH HIGH BLOOD GLUCOSE LEVEL. SUBSEQUENTLY, SHE EXPERIENCED VOMITING, DIABETIC KETOACIDOSIS AND BLOOD GLUCOSE LEVEL WAS REPORTED TO BE 349 MG/DL. SLIDING SCALE WAS SET UP AND SHE WAS GIVEN LONG ACTING INSULIN TO TREAT IT. THE SITE WAS ON THE RIGHT SIDE OF THE ABDOMEN AND THE PUMP WAS LYING ON THE BED NEXT TO HER. THE INFUSION HAD BEEN IN USE FOR TWO DAYS. THE INFUSIONS WERE STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. SHE WAS UNSURE ABOUT 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: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8494659 ↗
• InjuryApr 4, 2019Device Handling Problem; Device Handling Problem

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE SOFT CANNULA GOT DISLODGED, AS THE PATIENT HAD TROUBLE WHILE INSERTION OF THE INFUSION SET BECAUSE OF WEAK EYE SIGHT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8481947 ↗
• MalfunctionApr 1, 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 THERE WERE 5-6 INFUSION SETS IN WHICH THE TUBING BROKE AT THE TUBING CONNECTOR WHILE SITTING. THE SITE LOCATION WAS PATIENT'S ABDOMEN AND THE PUMP WAS ON THE SAME SIDE. THE INFUSIONS WERE STORED IN A COOL 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 8468153 ↗
• MalfunctionFeb 11, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ABOUT A CRACK IN THE TUBING. REPORTEDLY, LOCATION OF THE LEAK WAS AT TUBING, HOWEVER, THE TUBING DID NOT DETACH BUT CRACKED AND IT WAS ABOUT 6 INCHES FROM WHERE THE CONNECTOR FITS TO THE RESERVOIR. THE PATIENT STATED THAT PUMP WAS NOT DROPPED WITH SET IN PLACE. THE PATIENT HAD BLOOD GLUCOSE VALUES OF 600 MG/DL AT TIME OF INCIDENT. THE PATIENT TOOK 5 UNITS OF MANUAL INJECTIONS TO TREAT HIGH BLOOD GLUCOSE LEVELS. THE PATIENT WAS NEITHER IN THE EMERGENCY ROOM, NOR IN THE HOSPITAL AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8324844 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED AN ISSUE WITH HIS INFUSION SET. HE HAD INSERTED A NEW INFUSION SET LAST NIGHT AND WENT SWIMMING IN THE MORNING OF THIS REPORT AND HAD DISCONNECTED FROM THE PUMP AT THAT TIME. THE PATIENT RECONNECTED TO HIS PUMP AFTER SWIMMING THEN TOOK A SHOWER. HIS BLOOD GLUCOSE LEVEL STARTED TO INCREASE, AND HE NOTICED THAT INSULIN WAS NOT BEING DELIVERED TO HIS BODY. HE OBSERVED THAT THE INFUSION SET DETACHED FROM THE BASE, AT THE SITE CONNECTOR. THE SITE WAS AT THE RIGHT ABDOMEN AND THE PUMP WAS WORN ON THE RIGHT SIDE OF HIS HIP WITH THE BELT CLIP. THE INFUSION WAS IN USE FOR LESS THAN 24 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 8295679 ↗
• MalfunctionJan 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT INFUSION SET ON SEVERAL OCCASIONS HAVE DETACHED FROM THE TUBING AND FEW TIMES, IT CAME OUT OF THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8276837 ↗