Quick-set® MMT-392Recalls & 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
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244006294), received between Feb 3, 2019 and Jun 3, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Appropriate Device Problem Term/Code Not Available1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 3, 2024Leak/Splash; Leak/Splash
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN DENMARK. IT WAS REPORTED THAT PATIENT FACED INFUSION SET LEAKAGE FROM SITE/PIPE/KANYLA ON (B)(6) 2024. INFUSION SET HAS BEEN USED FOR LESS THAN A DAY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19447427 ↗MalfunctionJul 13, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2023, THE PATIENT'S MOTHER REPORTED THAT, A FEW DAYS AGO, THERE WAS A SMALL CRACK AND SUBSEQUENT LEAKAGE IN ONE OF THE NEEDLES OF THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314584 ↗MalfunctionMar 31, 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 WHILE SLEEPING, THE TUBING SNAPPED OFF AND WAS NO LONGER ATTACHED. HER BLOOD GLUCOSE LEVEL WAS 467 MG/DL, WHICH SHE TREATED WITH A SHOT. SHE CHANGED THE TUBING AND EVERYTHING WAS FINE. SHE ALSO HAD ISSUES FROM TIME TO TIME WITH GETTING THE QUICK RELEASE BACK ON AFTER TAKING A SHOWER. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8467977 ↗MalfunctionFeb 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
(B)(4). EVENT OCCURRED IN (B)(6). THE PATIENT REPORTED THAT TUBING GOT DETACHED AT THE QUICK RELEASE. THE PATIENT OBSERVED THAT INSULIN CAME OUT OF THE TUBING, 5 HOURS AFTER THE SET WAS CHANGED AND THIS ISSUE OCCURRED WITH ONE SET. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8300431 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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