Quick-set® MMT-393Recalls & 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 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05705244006270), received between Dec 28, 2018 and Jul 10, 2024 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component6
Patient problems
- No Known Impact Or Consequence To Patient4
- Hyperglycemia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CZECH REPUBLIC. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT ENCOUNTERED INFUSION SET NEEDLE WAS FRACTURED UPON INSERTION. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19709508 ↗MalfunctionNov 14, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2019, THE PATIENT REPORTED THAT THE INFUSION SET'S TUBING CAME APART FROM THE SIT WHILE SLEEPING. THE SITE LOCATION WAS THE PATIENT'S LEFT BUTTOCKS AND THE PUMP WAS LOCATED ON THE LEFT SIDE. THE INFUSION HAD BEEN IN USE FOR 2 DAYS AND THEY WERE STORED IN THE HOUSE. 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 9319803 ↗MalfunctionApr 19, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE TUBING DETACHED TWICE. THE PATIENT HAD HIGH BLOOD GLUCOSE LEVEL REPORTED TO BE 2 G/L (200 MG/DL). NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8530285 ↗MalfunctionApr 9, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE TUBING ON INSULIN DELIVERY INFUSION SET DETACHED FROM THE SET WHERE INSULIN WAS INFUSED INTO THE BODY. REPORTEDLY, THIS CAUSED A FAILURE OF INSULIN TO BE INFUSED INTO THE PATIENT'S BODY WHICH RESULTED IN AN ELEVATED BLOOD GLUCOSE LEVEL. FORTUNATELY, THE PATIENT'S CONTINUOUS GLUCOSE MONITOR ALERTED TO IT AND ALLOWED THE PATIENT TO EVALUATE IT AND CORRECT IT WITH AN INJECTION. MOREOVER, A NEW SET TUBING WAS INSTALLED, AND BLOOD GLUCOSE CONTROL WAS SUCCESSFULLY IMPLEMENTED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 8494837 ↗MalfunctionFeb 7, 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 TUBING DETACHED NEAR CANNULA SIDE. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8314354 ↗MalfunctionDec 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT STATED, TUBING WAS DISCONNECTED FROM THE HOUSING THAT CONNECTS TO THE BODY. THE INFUSION SET THE PATIENT USED GOT DETACHED FROM THE QUICK RELEASE (QR) IN THE MIDDLE OF NIGHT WHILE HE WAS SLEEPING. REPORTEDLY, THE PATIENT WAS USING THE INFUSION SET FOR 5 DAYS AS A LOT OF INSULIN WAS LEFT IN THE RESERVOIR. THE LOCATION OF THE DETACHMENT WAS WHERE THE TUBING CONNECTS TO THE QR. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WASN'T DROPPED WITH THE SET CONNECTED TO THE BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8202155 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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