Quick-set® Paradigm® MMT-396 (UDI 05705244006799)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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05705244006799), received between Jan 6, 2020 and Jan 6, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Inaccurate Delivery” (1 report).
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
- Inaccurate Delivery1
Patient problems
- Hyperglycemia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2020Inaccurate Delivery
I HAVE HAD AN ONGOING PROBLEM FOR SEVERAL WEEKS WITH MY CURRENT BOXES OF MEDTRONIC INSULIN PUMP INFUSION SETS. THE SETS STOP PROPERLY DELIVERING INSULIN AFTER A SHORT TIME, FROM 4-6 HOURS TO 12-14 HOURS. AS A RESULT, MY BLOOD SUGAR RISES TO 300 OR MORE AND WILL NOT COME DOWN UNTIL I CHANGE INFUSION SETS. THIS HAD LED TO EXTENDED TIMES OF SEVERE HIGH BLOOD USAGE, AND I AM CONCERNED IT MAY WORSEN DIABETES-RELATED EYE-PROBLEMS. I AM USING A MEDTRONIC IN-WARRANTY 723 INSULIN PUMP, WITH MMT-396 INFUSION SETS. ALL THE QUESTIONABLE INFUSION SETS ARE LOT 5268912. FDA SAFETY REPORT ID # (B)(4).
Patient problems: Hyperglycemia
MAUDE report 9558471 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.