Quick-set® Paradigm® MMT-396600Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244006751), received between Jan 19, 2019 and Dec 8, 2020 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2020Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA ON FRIDAY BECAUSE SHE HAD A KINKED CANNULA AND SHE ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVELS ON SATURDAY DUE TO A SECOND INFUSION WHICH WAS KINKED AS WELL. FURTHER, SHE STATED THAT THE MOST RECENT INCIDENT TOOK HER TO THE HOSPITAL WAS THE ONE ON SUNDAY, (B)(6) 2020 AT 8:30 AM. AT THE TIME OF THE INCIDENT, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 23.0 MMOL/L AND SHE HAD A BACK -UP PLAN WITH PENS AND NEEDLES. SUBSEQUENTLY, ON (B)(6) 2020, SHE WAS TAKEN TO THE EMERGENCY ROOM AND WAS ADMITTED IN CRITICAL CARE UNIT, AS HER BLOOD GLUCOSE LEVEL WAS 8.0 MMOL/L, AND THIS WAS AFTER THEY CHANGED THE INFUSION SET WHICH HAD A KINKED CANNULA. IT WAS ALSO REPORTED THAT THE INFUSION WAS CHANGED IN THE MORNING ON THE SAME DAY. REPORTEDLY, SHE HAD LARGE AMOUNT OF KETONES (DIABETIC KETOACIDOSIS) WHICH WAS DUE TO A BENT CANNULA AND SHE WAS SO CONFUSED THAT SHE DID NOT TAKE A SHOT. AFTER THREE DAYS OF HOSPITALIZATION, ON (B)(6) 2020 AT 4:00 PM, SHE WAS DISCHARGED FROM THE HOSPITAL. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 10.4 MMOL/L. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10969266 ↗
• InjuryOct 18, 2019Material Twisted/Bent; Material Twisted/Bent

  (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT HAD INCREASED BLOOD GLUCOSE LEVELS. FURTHER, AT THE TIME OF INCIDENT (AT 7:30 AM), HIS BLOOD GLUCOSE LEVEL WAS 23.6 MMOL/L, WHEREAS IT WAS 28.6 MMOL/L AT 2:45 PM. REPORTEDLY, THE PATIENT WAS ADMITTED IN THE INTENSIVE CARE UNIT FROM SATURDAY TO TUESDAY DUE TO DIABETIC KETOACIDOSIS. DURING HOSPITALIZATION, HE RECEIVED INSULIN DRIP AND CHANGED INFUSION SET INSERTION SITE. WHEN THE SITE WAS CHANGED AT THE HOSPITAL, THEY NOTICED THAT THE INFUSION SET'S NEEDLE WAS COMPLETELY BENT. FURTHER, IT WAS STATED THAT THE INSULIN WAS DELIVERED, BUT HIS CANNULA WAS BENT. HENCE THE SET WAS WET AND WHEN THE HEALTH CARE PROFESSIONAL REMOVED HIS INFUSION SET, IT WAS FOUND THAT THE CANNULA WAS 'CURLED UP'. THE SITE OF INSERTION WAS HIS LEFT/RIGHT SIDE OF BELLY BUTTON (3 INCH AWAY FROM BELLY) AT HIS ABDOMEN. 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 9206942 ↗
• MalfunctionJul 18, 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 CAME APART NEAR THE SET WHILE SLEEPING AT NIGHT. THE SITE LOCATION WAS LEFT SIDE OF BUTTOCK AREA AND THE PUMP WAS ATTACHED TO THE PAJAMA BOTTOM ON THE RIGHT SIDE. THE INFUSION HAD BEEN IN USE FOR TWO DAYS AND THE INFUSIONS WERE STORED IN A CUPBOARD AT REGULAR TEMPERATURE. REPORTEDLY, THE PATIENT 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 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 8801436 ↗
• MalfunctionApr 29, 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 CHANGED THE SET THE NIGHT BEFORE THIS REPORT AND WOKE UP IN THE MORNING, TUBING WAS DISCONNECTED FROM THE SITE. THE PATIENT WOKE UP AT NIGHT AND HER SET WAS FINE. THEN SHE WOKE UP EARLY IN THE MORNING AND WHEN SHE WALKED TO THE RESTROOM SHE NOTICED THAT THE TUBING CAME APART AT THE QUICK RELEASE. THE SITE LOCATION WAS AT THE LEFT BUM CHEEK AND THE PUMP WAS ON THE SAME SIDE BUT IN THE FRONT. THE INFUSION HAD BEEN IN USE FOR 12 HOURS. REPORTEDLY, THE INFUSIONS WERE STORED IN A PANTRY AND IT WAS COOL. 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. IN THE INVESTIGATION 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 8559898 ↗
• 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 AT THE QUICK RELEASE. THE PATIENT HAD TWO EPISODES OF HIGH BLOOD GLUCOSE THE PREVIOUS NIGHT. THE FIRST EVENT OCCURRED WHILE THE PATIENT WAS SLEEPING AND THE SECOND ONE OCCURRED WHILE THE PATIENT WAS WATCHING TELEVISION ON SOFA. THE SITE WAS INITIALLY THE PATIENT'S LEG AND LATER TO RIGHT SIDE OF STOMACH AND THE PUMP WAS LOCATED ON THE BELT CLIP. THE INFUSION HAD BEEN IN USE FOR FEW HOURS. THE INFUSIONS WERE STORED IN A DRAWER IN THE KITCHEN. 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 8447260 ↗
• 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 SLEEPING THE INFUSION SET TUBING DETACHED AT QUICK RELEASE. THE PATIENT WOKE UP AND HAD HIGH BLOOD GLUCOSE LEVEL (16 MMOL/L) DUE TO TUBING DETACHMENT THEREFORE SHE CHANGED HER INFUSION SET. THE SITE WAS AT THE RIGHT LEG. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8264746 ↗
• MalfunctionJan 19, 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 DUE TO UNSTABLE BLOOD GLUCOSE LEVEL HE WOKE UP AT NIGHT AND NOTICED THE SET WAS COMPLETELY DISCONNECTED AT QUICK RELEASE AND HAD ISSUES WITH 2 OTHER SETS WHERE HE FOUND MOISTURE AROUND THE TAPE AT THE SITE WHICH HAPPENED IN A SPAN OF 18 DAYS. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8263036 ↗