Quick-set® Paradigm® MMT-399T (UDI 05705244020467)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05705244020467), received between Apr 3, 2019 and May 18, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Material Twisted/Bent” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 18, 2020Break; Break

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS OF 551 MG/DL AFTER EATING DINNER. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS OF THE HIGH BLOOD GLUCOSE LEVELS, BUT THEY WERE ABLE TO TREAT THE ISSUE WITH THE INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND WAS ABLE TO CHANGE THE INFUSION SET OF THEIR INSULIN PUMP. THE CUSTOMER DID NOT RETURN THE INSULIN PUMP BACK FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10067536 ↗
• InjuryMay 5, 2020Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 421 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT ALARM WITH AN INSULIN FLOW BLOCKED ALARM EVEN WHEN THEY HAD A BENT INFUSION SET CANNULA. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE USING INSULIN PUMP BOLUS. THE INFUSION SET WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10026790 ↗
• InjuryApr 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 475 MG/DL, 550 M G/DL, 560 MG/DL, BELOW 400 MG/DL. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS DIZZINESS. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WAS NOT USING AUTO MODE. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Dizziness; Hyperglycemia

  MAUDE report 9979373 ↗
• InjuryAug 30, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 427 MG/DL. CUSTOMER STATED THAT THE INFUSION SET HAD LEAK. CUSTOMER DISCONNECTED BEFORE OFFERING HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8949686 ↗
• InjuryApr 3, 2019Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED LACK OF INSULIN DELIVERY DUE TO SITE ISSUES AND BENT CANNULAS. THE CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER DID NOT REPORT HOW THEY WERE TREATED FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INFUSION SET WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8476744 ↗