Quick-set® Paradigm® MMT-396TRecalls & 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 13, 2026 from official FDA records · Editorial policy
- 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 05705244020528), received between Aug 30, 2019 and Aug 30, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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
- Insufficient Flow or Under Infusion1
- Material Twisted/Bent1
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.
InjuryAug 30, 2019Insufficient Flow or Under Infusion; Material Twisted/Bent; Insufficient Flow or Under Infusion; Material Twisted/Bent
CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF OVER 500 MG/DL. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 519 MG/DL. THE CUSTOMER DID NOT PROVIDE THE SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE INFUSION SET WAS BENT WHICH CAUSED THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH SHOTS AND CHANGING INFUSION SET. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8951374 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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