Quick-set® Paradigm® MMT-394600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05705244006195), received between Jan 17, 2019 and Mar 11, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2021Detachment 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 CANNULA WAS DETACHED FROM INFUSION SET AS IT CAME OUT OF THE PLASTIC CONNECTOR WHILE THE PATIENT WAS WORKING (IMPLIED TO A LOT OF PHYSICAL ACTIVITY). THE PATIENT STATED THAT THE TAPE WAS STILL ATTACHED TO THE SKIN BUT NOT THE CANNULA. THE SITE LOCATION WAS PATIENT'S HIP AS THE PATIENT COULD NOT USE HIS ABDOMEN SINCE HE HAD BEEN DIABETIC FOR SO LONG AND THE PUMP WAS IN HIS POCKET. REPORTEDLY, THE INFUSIONS WERE STORED 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 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11468228 ↗
• MalfunctionNov 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2019, THE PATIENT REPORTED THAT SHE HAD TWO INF SETS FROM THE SAME BOX THAT DETACHED FROM THE QUICK RELEASE, ONE IN THE MORNING WHEN SHE WOKE UP AFTER SLEEPING AND THE OTHER WHEN SHE WAS AT WORK. THE SITE LOCATION WAS BOTH OF HER ARMS ONCE RIGHT, LAST NIGHT LEFT AND THE PUMP WAS LOCATED ON THE CENTER OF HER BODY. THE INFUSION HAD BEEN USED FOR TWO FULL DAYS AND THEY WERE STORED IN THE BEDROOM CLOSET (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. 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 9382286 ↗
• MalfunctionJan 17, 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 TUBING DETACHED AT THE SITE AND HAD BLOOD GLUCOSE LEVEL OF 7.8 MMOL/L. THE SITE WAS AT THE ABDOMEN AND THE PUMP WAS WORN ON THE LEFT SIDE. THE PATIENT WAS NOT ABLE TO USE THE SET AT ALL. 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 8256148 ↗