Quick-set® Paradigm® MMT-398600Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244006676), received between Jan 16, 2019 and Feb 19, 2021 — classified as 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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) 2021, IT WAS REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE WHILE THE PATIENT WAS SLEEPING. THE SITE LOCATION WAS RIGHT SIDE OF PATIENT'S ABDOMEN AND THE PUMP WAS LOCATED ON THE BED. MOREOVER, THE INFUSION HAD BEEN USED FOR TWO DAYS. REPORTEDLY, THE INFUSIONS WERE STORED IN THE KITCHEN PANTRY. THE PATIENT WAS UNSURE WHETHER THERE WAS STRESS OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11347393 ↗
• MalfunctionApr 13, 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 HER INFUSION SET DETACHED FROM THE SITE AT THE QUICK RELEASE WHEN SHE WAS IN THE HOUSE. SHE WAS UNABLE TO GET THE SET TO LOCK BACK SUCCESSFULLY WITH HER SITE. SUBSEQUENTLY, SHE EXPERIENCED HIGH BLOOD GLUCOSE LEVEL, WHICH WAS TREATED WITH A MANUAL INJECTION AND SHE ALSO CHANGED HER SET. THE SITE LOCATION WAS ABOVE BELLY BUTTON AND THE PUMP WAS ON THE SAME SIDE AS THE SITE. THE INFUSION HAD BEEN IN USE FOR LESS THAN 24 HOURS 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 THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 8512006 ↗
• MalfunctionApr 12, 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 HER INFUSION SET WAS DETACHED FROM THE SITE AT THE QUICK RELEASE WHEN SHE WAS IN THE HOUSE. SHE WAS UNABLE TO GET THE SET TO LOCK BACK SUCCESSFULLY WITH HER SITE, SO SHE REMOVED IT. DUE TO THIS, SHE HAD HIGH BLOOD GLUCOSE LEVEL, WHICH SHE TREATED USING A MANUAL INJECTION. THE SITE LOCATION WAS ABOVE BELLY BUTTON AND THE PUMP WAS WORN ON THE SAME SIDE AS THE SITE. THE INFUSION HAD BEEN IN USE FOR LESS THAN 24 HOURS. 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 8511171 ↗
• 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 THAT THE INFUSION SET TUBING'S CAME APART AT QUICK RELEASE WHILE SLEEPING. THE SITE WAS AT THE LEG AND THE PUMP WAS LOCATED ON THE BELT LOOP. THE INFUSION WAS 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. THE PATIENT WAS UNCERTAIN WHETHER THERE WAS STRESS OR PULL ON THE TUBING AS HE WAS SLEEPING WHEN HE WOKE UP THE TUBING WAS DANGLING 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 8467989 ↗
• MalfunctionJan 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  (B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT IMMEDIATELY AFTER INSERTION, HIS INFUSION SET DETACHED AT THE QUICK RELEASE WHILE HE WAS CONNECTING THE TUBING TO THE SITE. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO HIS BODY. REPORTEDLY, IT WAS THE THIRD INFUSION SET FROM THE BOX WITH WHICH THE PATIENT HAD ISSUE. THE DEFECTIVE AND UNUSED SETS WERE REPLACED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8251704 ↗