Quick-set® Paradigm® MMT-394 (UDI 05705244006218)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05705244006218), received between Dec 8, 2020 and Dec 6, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT FACED FOUR INFUSION SET BLOCKED ALARM ON (B)(6) 2024. BLOOD GLUCOSE LEVEL WAS BETWEEN 480-530 MG/DL AT THE TIME OF THE EVENT. PATIENT THEN CHANGED ALL THE SETS AND RESERVOIRS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20862759 ↗
• InjuryDec 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT FACED FOUR INFUSION SET BLOCKED ALARM ON (B)(6) 2024. BLOOD GLUCOSE LEVEL WAS BETWEEN 480-530 MG/DL AT THE TIME OF THE EVENT. PATIENT THEN CHANGED ALL THE SETS AND RESERVOIRS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20862758 ↗
• InjuryDec 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT FACED FOUR INFUSION SET BLOCKED ALARM ON (B)(6) 2024. BLOOD GLUCOSE LEVEL WAS BETWEEN 480-530 MG/DL AT THE TIME OF THE EVENT. PATIENT THEN CHANGED ALL THE SETS AND RESERVOIRS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20862753 ↗
• InjuryDec 6, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT FACED FOUR INFUSION SET BLOCKED ALARM ON (B)(6) 2024. BLOOD GLUCOSE LEVEL WAS BETWEEN 480-530 MG/DL AT THE TIME OF THE EVENT. PATIENT THEN CHANGED ALL THE SETS AND RESERVOIRS. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20862751 ↗
• MalfunctionDec 3, 2024Infusion or Flow Problem; Infusion or Flow Problem

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT FACED INSULIN FLOW BLOCKED ALARM EVENT ON (B)(6) 2024. THE BLOCKAGE WAS IN THE TUBING. THE PATIENT REPLACED THE INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Hyperglycemia

  MAUDE report 20832890 ↗
• MalfunctionNov 26, 2024Leak/Splash; Leak/Splash

  REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2024 . NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786365 ↗
• MalfunctionDec 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES THE PATIENT REPORTED THAT THERE WERE THREE SETS IN THE LAST 2 WEEKS NOW, IN WHICH THE TUBING SEPARATED FROM THE QUICK RELEASE/ SITE CONNECTOR. INITIALLY, SHE THOUGHT IT WAS OF HER BECAUSE AS SHE WAS SLEEPING WHEN IT HAPPENED, BUT THE REST OF THE INFUSION SETS HAD DETACHED FROM THE SITE WHEN SHE WAS JUST SITTING. FURTHER, SHE JUST NOTICED IT WHEN SHE SMELT AN INSULIN AND FELT THAT HER PANTS GOT WET BY THE INSULIN. THE SITE LOCATION WAS HER ABDOMEN AND THE PUMP WAS LOCATED ON THE BELT LINE. THE INFUSION HAD BEEN USED FOR ONE DAY. MOREOVER, THE INFUSION SETS WERE NOT STORED OR USED IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. FURTHER, THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. CURRENTLY, HER BLOOD GLUCOSE LEVEL WAS 134 MG/DL. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10972832 ↗