Skip to content

Quick-set® MMT-390Recalls & reported problems

Unomedical A/S · Single use infusion set for subcutaneous infusion. The infusion set must be used as described in the Instruction for Use. · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05705244006652), received between Feb 9, 2019 and Apr 5, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Detachment of Device or Device Component3

Patient problems

  • No Known Impact Or Consequence To Patient3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED TUBING DETACHMENT AT THE QUICK RELEASE WHILE GETTING IN AND OUT OF HIS CAR. WHILE TRYING TO DISCONNECT FROM THE QUICKSET AT THE QUICK RELEASE, THE WHOLE THING CAME OUT. HE WAS TRAVELING AT THAT TIME. IT DETACHED THRICE, AND HE PINCHED IT TO TURN BUT IT WAS NOT GETTING RELEASED. THERE WAS A TIME WHEN THE INFUSION WAS ON FOR A DAY AND A HALF. AS SOON AS HE INSERTED THE SECOND ONE, INSULIN WENT EVERYWHERE. THE THIRD ONE WAS ON FOR ABOUT HALF A DAY WHEN HE NOTICED HIS BLOOD GLUCOSE LEVEL WAS NOT GOING DOWN AND REALIZED THAT THE TUBING CAME OUT. THE SITE LOCATION WAS EITHER SIDE AND THE PUMP WAS LOCATED ON THE SAME SIDE IN RELATION TO THE SITE. 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. REPORTEDLY, PATIENT'S BLOOD GLUCOSE LEVEL WAS AT 162 MG/DL IN THE MORNING OF THIS REPORT. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8485928 ↗
  • MalfunctionApr 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

    (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT, THE INFUSION SET'S TUBING DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN CAME OUT OF THE TUBING ABOUT SIX HOURS AFTER THE SET WAS CHANGED. THIS ISSUE OCCURRED WITH 10 SETS. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8468661 ↗
  • MalfunctionFeb 9, 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 INFUSION SET'S TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED INSULIN OUT OF THE TUBING ABOUT 2 HOURS AFTER CHANGING THE SET. THE PATIENT HAD THIS ISSUE WITH SIX SETS. NO FURTHER INFORMATION AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8324462 ↗

Other Set, Administration, Intravascular devices

All Set, Administration, Intravascular devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.