Quick-set® MMT-391Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05705244006638), received between Jan 19, 2019 and Jul 5, 2019 — classified as 1 injury, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient2
- Elevated Ketones/ Diabetic Ketoacidosis1
- Hyperglycemia1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 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 HAD DETACHED AT THE QUICK RELEASE AND THIS ISSUE OCCURRED WITH TEN SETS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8763170 ↗InjuryApr 25, 2019Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED BENT CANNULA ISSUE. HIS BLOOD GLUCOSE LEVEL WAS 470 MG/DL AND HE SUFFERED FROM VOMITING AND DEHYDRATION. THE EMERGENCY MEDICAL SERVICE WAS CALLED, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL. HE WAS GIVEN INSULIN DRIP AS CORRECTIVE TREATMENT. THE PATIENT WAS HOSPITALIZED FOR TWO AND A HALF DAYS. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 8548023 ↗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 TUBING CAME OUT OF THE CANNULA. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8468278 ↗MalfunctionJan 19, 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 WHEN SHE WOKE UP IN THE MORNING, SHE HAD HIGH BLOOD GLUCOSE LEVEL (27 MMOL/L) AS SHE DID NOT KNOW WHETHER SHE HAD INSULIN AT NIGHT OR NOT. REPORTEDLY, THE TUBING CAME APART FROM WHERE IT WAS ATTACHED TO HER SITE. THE PATIENT TREATED HIGH BLOOD GLUCOSE LEVEL WITH HER PUMP AND IT WAS STILL COMING DOWN. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 8263039 ↗
Other Set, Administration, Intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 reports
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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