Quick-set® Paradigm® MMT-399T (UDI 05705244020436)Recalls & 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
All models of Quick-set Paradigm (23)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244020436), received between Aug 14, 2024 and Jun 26, 2025 — classified as 1 injury, 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
- Infusion or Flow Problem2
- Adverse Event Without Identified Device or Use Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Hypoglycemia1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ISRAEL IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BREAK EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR ONE DAY. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22333921 ↗InjuryApr 17, 2025Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ISRAEL. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT OF LOW BLOOD GLUCOSE RESULTING IN HOSPITALIZATION ON (B)(6) 2025. LENGTH OF HOSPITALIZATION WAS GREATER THAN 24 HOURS. TREATMENT FOR LOW BLOOD GLUCOSE WAS USING SYRINGE TO INCREASE SUGAR. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hypoglycemia
MAUDE report 21854093 ↗MalfunctionNov 29, 2024Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ISRAEL. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS IN THE TUBING. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20808743 ↗MalfunctionAug 23, 2024Infusion or Flow Problem; Infusion or Flow Problem
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE ISRAEL. ON 25/JUL/2024, IT WAS OBSERVED THAT THE OCCLUSION OCCURED THAT PREVENTS THE FLOW OF INSULIN DURING THERAPY. IT WAS CONFIRMED THAT THE CUSTOMER ABLE TO REMOVE THE SET AT THIS TIME TO TEST THE SITE PORTION OF THE INFUSION SET. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20058035 ↗MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ISRAEL. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WAS BENT AND BREAK AT ABDOMEN. THE PATIENT ALSO REPORTED THAT THE CANNULA WAS STILL ON THE SKIN AND DID NOT RECEIVE ANY MEDICAL TREATMENT BECAUSE OF CANNULA FRACTURING WHILE IN THE BODY. THE INFUSION SET WAS IN USE FOR 4 DAYS. NO FURTHER INFORMATION AVAILABLE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19984940 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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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