Quick-set® Paradigm® MMT-399600Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05705244006317), received between Jan 16, 2019 and Jun 4, 2021 — classified as 2 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (23 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISSUES WITH INSTALLING NEW INFUSION SETS, AS THE INFUSION SET'S TUBING CAME APART. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11937032 ↗
• MalfunctionApr 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2021, THE PATIENT REPORTED OF HEADACHE DUE TO HIGH BLOOD GLUCOSE LEVEL WHICH WAS AFTER THE INFUSION SET'S TUBING HAD DETACHED AS IT WAS NOT CONNECTED CORRECTLY. THE PATIENT TRIED TO TREAT THE HIGH BLOOD GLUCOSE LEVEL WITH MANUAL INJECTIONS (FOUR UNITS). AT THE TIME OF THE INCIDENT THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 24.2 MMOL/L. THE INFUSION SET HAD BEEN CHANGED THREE DAYS AGO. CURRENTLY, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 20.3 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 11662627 ↗
• MalfunctionFeb 19, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2020, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE WHILE SLEEPING. THE SITE LOCATION WAS THE PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE WAIST BAND. THE INFUSION HAD BEEN USED FOR ONE AND A HALF DAYS. MOREOVER, THE INFUSION SETS 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 ON THE RETURNED USED DEVICE (ONE TUBING), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347364 ↗
• MalfunctionJan 11, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 15-JUN-2021: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE AWARENESS DATE. MOREOVER, THE RESULT OF THE (COMPLAINT INVESTIGATIONS) VISUAL INSPECTION AND TESTS FOR STATIC PULL WERE PERFORMED ON THE RETURNED USED DEVICE (ONE SET) WHICH SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING-TUBING CONNECTOR. BASED ON THE RESULT: TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING CAME APART AT THE TUBING CONNECTOR WHILE SLEEPING. THE SITE LOCATION WAS LEFT SIDE OF THE PATIENT'S ABDOMEN AND THE PUMP WAS WORN IN RELATION TO THE SITE. THE INFUSION SET HAD BEEN USED FOR SIX HOURS. 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 STRESS OR PULL ON THE TUBING AS THE PATIENT WAS SLEEPING, WHEN THIS ISSUE OCCURRED. FURTHER, 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 11146420 ↗
• MalfunctionSep 29, 2020Connection Problem; Detachment of Device or Device Component; Connection Problem; Detachment of Device or Device Component

  ON 28-JAN-2021: FOLLOW UP INFORMATION WAS SUBMITTED FOR UPDATING HEALTH EFFECT IMPACT CODE AND RESULT OF THE COMPLAINT INVESTIGATION OF RETURNED USED AND UNUSED DEVICES (1 USED SET, 3 UNUSED SETS AND 1 USED CANNULA). IN THE USED SET (ONE), IT WAS FOUND THAT THE CONNECTION BETWEEN TUBING CONNECTOR AND CANNULA DOES NOT MAKE THE CLICK, DUE TO THE CLICK-LEGS OF TUBING CONNECTOR HAVE DAMAGES (DEFORMED). THE STATIC PULL TEST RESULTS WERE FOUND WITHIN SPECIFICATIONS. BASED ON THE RESULT: COMPONENT CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED BY THE PATIENT THAT THE INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE WHILE SLEEPING. THE PATIENT HAD SIX INFUSION SETS THAT DETACHED AFTER ONE DAY OR TWO. THE SITE LOCATION WAS ON THE PATIENT'S SIDE AND THE PUMP WAS LOCATED IN THE FRONT OF THE INFUSION SETS. THE INFUSION SET HAD BEEN USED FOR ONE DAY AND 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10598340 ↗
• InjuryJan 27, 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 AND HAD HIGH BLOOD GLUCOSE LEVELS OF 29 MMOL/L AT THE TIME OF INCIDENT. SUBSEQUENTLY, ON (B)(6) 2019 AT 1:00 AM, SHE WAS ADMITTED TO THE HOSPITAL AS HER BLOOD GLUCOSE LEVELS WERE 29 MMOL/L AND THEY CONTINUED TO RISE, ALSO SHE EXPERIENCED DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, THE INFUSION SET WAS REMOVED, AND A BENT CANNULA WAS NOTICED. THE SITE LOCATION WAS HER ABDOMEN AND THE INFUSION SET HAD BEEN USED FOR THE FIRST DAY. SHE RECEIVED INTRAVENOUS INSULIN AS CORRECTIVE TREATMENT. SHE WAS ADMITTED FOR TWO 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 9630795 ↗
• 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 REPORTED STATED THAT HER SON'S INFUSION SET'S TUBING CAME APART AT THE QUICK RELEASE (WHERE THE NEEDLE IS). THE SITE LOCATION WAS HIS LEG AND THE PUMP WAS WORN ON THE HIP. REPORTEDLY, THE HEIGHT OF THE PATIENT WAS 6 FEET AND 1 INCH. 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 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 9393415 ↗
• MalfunctionSep 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 PATIENT'S MOTHER NOTICED AN INFUSION SET'S TUBING DETACHMENT FROM THE SITE LOCATION AT QUICK RELEASE WHICH CAUSED HIGH BLOOD GLUCOSE LEVEL. THIS ISSUE OCCURRED FIVE TIMES AND PATIENT'S MOTHER SAVED THREE USED SETS THAT HAD THE DETACHMENT. THE SITE LOCATION WAS AT PATIENT'S ARM AND THE PUMP WAS LOCATED AT THE SAME SIDE TO THE SITE AT THE WAIST. THE INFUSION HAD BEEN 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 PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9108164 ↗
• MalfunctionJul 18, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6) THE PATIENT'S MOTHER REPORTED THAT A NIGHT BEFORE THIS REPORT, SHE WENT TO GIVE BOLUS TO HER SON WHILE HE WAS ASLEEP BUT THEN SHE SMELLED INSULIN AND FOUND THAT THE TUBING WAS DETACHED CLOSE TO THE SITE LOCATION. THE TUBING LOOKED COMPLETELY INTACT AND WAS NOT PULLED. IT LOOKED LIKE IT HAD SLID OUT. THE SITE LOCATION WAS UPPER RIGHT ARM AND THE PUMP WAS IN A CASE IN HIS RIGHT POCKET. THE INFUSION HAD BEEN IN USE WAS ALMOST THREE DAYS AND THE INFUSIONS WERE STORED IN AN ARMOIRE IN THE HOUSE WITH AN AIR CONDITIONER. 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. UPON INVESTIGATION OF THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8801424 ↗
• MalfunctionMay 31, 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 DISCONNECTED FROM THE CONNECTOR AND THE PATIENT WAS UNABLE TO RECONNECT THE INFUSION SET TO HIS BODY. THE DETACHMENT OCCURRED CLOSE TO THE QUICK RELEASE WHILE THE PATIENT WAS DRIVING. THE PATIENT STATED THAT HE HAD TO LEAVE WORK EARLY AND CAME HOME BECAUSE HIS BLOOD GLUCOSE LEVEL KEPT RISING. IT WAS REPORTED TO BE 22 MMOL/L, WHICH HE CORRECTED USING A NEEDLE WITH 7 UNITS OF INSULIN. THE SITE LOCATION WAS UPPER BUTTOCKS AND THE PUMP WAS WORN CLOSE TO THE INFUSION SITE. 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. THERE WAS NO 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: Hyperglycemia

  MAUDE report 8656926 ↗
• MalfunctionApr 11, 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 QUICK RELEASE GOT DETACHED AND FELL OFF THE SITE. THE SITE LOCATION WAS THE PATIENT'S HIP. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8502646 ↗
• MalfunctionApr 9, 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 WHILE SLEEPING, HER TWO OF THE INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THIS ISSUE HAPPENED LAST NIGHT AND 2 NIGHTS AGO. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8494715 ↗
• MalfunctionApr 8, 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 ON THE DAY OF THIS REPORT, SHE WOKE UP AND FOUND THAT THE TUBING WAS DETACHED FROM THE SITE AND WAS HANGING. SHE FACED THIS ISSUE WITH TWO INFUSION SETS. SHE WAS FINE AS SHE HAD CHANGED THE SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490425 ↗
• MalfunctionApr 8, 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 ON THE DAY OF THIS REPORT, SHE WOKE UP AND FOUND THAT THE TUBING WAS DETACHED FROM THE SITE AND WAS HANGING. SHE FACED THIS ISSUE WITH TWO INFUSION SETS. SHE WAS FINE AS SHE HAD CHANGED THE SITE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8490369 ↗
• MalfunctionApr 5, 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'S ADHESIVE WAS STICKING BUT TUBING CONNECTOR DID NOT STICK INTO CANNULA HOUSING PROPERLY, HOWEVER, THE CANNULA STAYED ON THE BODY. THIS HAD HAPPENED FOURTH TIME FROM THIS BOX OF INFUSION SETS AND FIRST OCCURRENCE WAS TWO WEEKS AGO. THE PATIENT'S MOTHER HAD SEEN THE TUBING WAS HANGING OFF. THE PATIENT'S MOTHER CONFIRMED THAT HER SON DID NOT PLAY WITH THE CONNECTOR. REPORTEDLY, WHEN THE PATIENT'S MOTHER NOTICED THAT THE SITE WAS DISCONNECTED, THE BLOOD GLUCOSE LEVEL WAS 32 MMOL/L AND HE WAS GIVEN A CORRECTION THROUGH THE PUMP. SUBSEQUENTLY, HIS BLOOD GLUCOSE CAME TO 19 MMOL/L. THE PATIENT'S MOTHER WAS CERTAIN THAT THE HIGH BLOOD GLUCOSE WAS DUE TO THE TUBING WHICH WAS NOT CONNECTED TO THE BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8485829 ↗
• MalfunctionMar 31, 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 HER DAUGHTER HAD ISSUES IN THE PAST WITH INFUSION SET'S TUBING DETACHMENT FROM HER DAUGHTER'S SITE. THE LAST TIME WHEN THE DETACHMENT OCCURRED WAS TWO NIGHTS BEFORE THIS REPORT WITH TWO INFUSION SETS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8468015 ↗
• MalfunctionMar 31, 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 HAVING ISSUES WITH THE TUBING COMING OUT OF THE INFUSION SET AND DETACHING AT THE QUICK RELEASE/SITE CONNECTER WHILE SLEEPING. PATIENT'S BLOOD GLUCOSE LEVEL AT THE TIME OF THIS REPORT WAS 22.6 MMOL/L, WHICH WAS TREATED WITH A PUMP AND PATIENT ALSO HAD TO PUT ON A NEW SET. THIS WAS THE THIRD TIME WHEN THIS ISSUE HAD OCCURRED. THE FIRST TIME, HER BLOOD GLUCOSE WAS 16.0 MMOL/L AND SHE HAD TO CHANGE HER SET AND TREAT IT WITH AN INSULIN PUMP. THE SITE LOCATION WAS UPPER ABDOMEN, THE FIRST TIME AND THE LATEST ONE WAS PATIENT'S UPPER THIGH WITH THE PUMP WORN IN HER BRA. THE INFUSIONS WERE STORED IN HER ROOM AT ROOM 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: Hyperglycemia

  MAUDE report 8468006 ↗
• MalfunctionMar 25, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT HER INFUSION SET'S TUBING BROKE OFF AT THE QUICK RELEASE IN THE NIGHT. SHE HAD ISSUES WITH TWO QUICK SETS FROM THE SAME BOX. REPORTEDLY, HER BLOOD GLUCOSE LEVEL WENT ABOVE 30 MMOL/L AND SHE CORRECTED IT WITH HER PUMP. SHE DID NOT KNOW IF PUMP WAS DROPPED OR BUMPED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8447161 ↗
• MalfunctionMar 25, 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 AGAIN AT THE QUICK RELEASE. REPORTEDLY, SHE WORE THE PUMP AND TUBING UNDER HER NIGHT SHIRT SO THERE WAS NO WAY FOR IT TO GET CAUGHT AT NIGHT. SHE WORE PUMP ON SAME SIDE AS INSERTION. IT HAD HAPPENED AT DIFFERENT TIMES OF THE DAY AND FROM DIFFERENT BOXES. SHE SAID THERE WAS NO STRESS ON THE TUBING. NO FURTHER INFORMATION AVAILABLE3003442380

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8447111 ↗
• MalfunctionMar 3, 2019Crack; Crack

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT'S HUSBAND REPORTED THAT FOR THE LAST FOUR DAYS PRIOR TO THIS REPORT, THE PATIENT HAD HIGH BLOOD GLUCOSE LEVEL AND SELF-TREATED IT WITH MULTIPLE DAILY INJECTION. THE PATIENT WENT TO THE HOSPITAL WITH DIABETES KETOACIDOSIS OVERNIGHT. THE PATIENT STATED THAT SET WAS LEAKING AT THE QUICK RELEASE AS IT WAS NOT TIGHTLY CONNECTED, AND THIS ISSUE OCCURRED WITH THREE SETS. THEY NOTICED A CRACK IN THE QUICK RELEASE. REPORTEDLY, THE PUMP WAS NOT DROPPED WITH SET IN PLACE. THE PATIENT WAS HOSPITALIZED FOR MORE THAN 3 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 8384852 ↗
• MalfunctionFeb 15, 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 INFUSION SET TUBING DETACHMENT AT THE SITE. THE SITE LOCATION WAS ABDOMEN AND THE PUMP WAS WORN ON THE BELT. 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 8342473 ↗
• InjuryFeb 15, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT HIS FATHER FOUND HIM UNCONSCIOUS AND ADMITTED HIM IN THE EMERGENCY ROOM IN THE HOSPITAL FOR LOW BLOOD GLUCOSE LEVEL (2.1 MMOL/L) AND SEIZURE. REPORTEDLY, THE PATIENT RECEIVED TREATMENT THROUGH INTRAVENOUS ROUTE AND UNDERWENT ELECTROENCEPHALOGRAM, ULTRASOUNDS (BRAIN), BLADDER AND KIDNEY EXAM AND VARIOUS BLOOD INVESTIGATIONS. THE PATIENT WAS HOSPITALIZED FOR 3 WEEKS. CURRENTLY, THE BLOOD GLUCOSE WAS REPORTED AS 10 MMOL/L. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hypoglycemia

  MAUDE report 8342173 ↗
• MalfunctionFeb 7, 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 TUBING HAD DETACHED AT THE TUBING CONNECTOR AND THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS PATIENT'S ARM AND STOMACH. THE PUMP WAS WORN ON THE PATIENT'S HIP. THE INFUSION HAD BEEN IN USE FOR 1-2 DAYS AND THE INFUSIONS WERE STORED IN THE KITCHEN CUPBOARD. IT WAS UNCERTAIN WHETHER THERE WAS 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 8314226 ↗
• MalfunctionJan 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 HAD PROBLEMS WITH THE QUICK SET INFUSION SETS AS INSULIN FLOW WAS BLOCKED WHEN PATIENT TRIED TO GIVE BOLUS. REPORTEDLY, TUBE WAS DETACHED FROM ONE INFUSION FROM THE PREVIOUS BOX WHICH PATIENT HAD USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280309 ↗
• MalfunctionJan 25, 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 BROKE AT THE QUICK RELEASE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8277017 ↗