Quick-set® Paradigm® MMT-387600Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244006478), received between Jan 27, 2019 and Sep 13, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 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, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE WHEN INJECTED IT IN THE ARM. REPORTEDLY, THIS ISSUE OCCURRED THREE TIMES AND HAPPENED LAST WEEKEND. THE PATIENT ADMINISTERED A CORRECTION BOLUS IN THE NIGHT AS THE BLOOD GLUCOSE LEVEL WAS ABOUT 12 MMOL/L. THE SITE LOCATION WAS PATIENT'S ARM, AND THE PUMP WAS LOCATED ON THE WAIST. MOREOVER, THE INFUSION SETS WERE USED ON DIFFERENT DAYS. REPORTEDLY, THE INFUSIONS WERE STORED IN THE BASEMENT. THERE WAS SOME STRESS ON THE TUBING WHILE THE PATIENT WAS SLEEPING, 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 12458920 ↗
• MalfunctionJan 11, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  ON 08-MAR-2021: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE AWARENESS DATE. ALSO, A VISUAL INSPECTION AND STATIC PULL OF TUBING-TUBING CONNECTOR TEST WERE PERFORMED ON THE RETURNED USED DEVICE (1 SET), IT WAS FOUND THAT ALL THE TEST RESULTS WERE WITHIN SPECIFICATIONS. BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. ON (B)(6) 2020, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING DETACHED AT THE TUBING CONNECTOR. THE PATIENT STATED THAT SHE HAD A BLOCKAGE AT THE TUBING CONNECTOR, AND SHE HAD TO CHANGE THE ENTIRE INFUSION SET. MOREOVER, THE PATIENT HAD NOT USED THE INFUSION SET. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11146162 ↗
• 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 THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. THIS EVENT HAPPENED ALL THE WEEKEND, WHEN THE PATIENT WAS NOT AT HOME (OUTDOOR). THE SITE WAS RIGHT SIDE OF ABDOMEN AND THE PUMP WAS ALWAYS ON THE SIDE. THE INFUSION WAS USED FOR LESS THAN 24 HOURS. THE INFUSIONS WERE STORED INSIDE THE CUPBOARD. 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 8490704 ↗
• 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 REPORTED THAT TUBING DETACHED AT QUICK RELEASE FROM THE INFUSION SET DURING THE NIGHT WHILE THE INFUSION SET WAS STILL ON THE BODY AND PATIENT HAD NOT MOVED THEREFORE HE INSERTED A NEW INFUSION SET. THIS ISSUE OCCURRED SECOND TIME. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8280311 ↗