Quick-set® Paradigm® MMT-398Recalls & 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
Quick summary
This Unomedical Quick-set Paradigm MMT-398 is a single-use infusion set that places insulin under the skin through a small cannula. Most of the 70 reports describe the set coming apart or its soft tubing bending and kinking, which can block insulin delivery and leave patients with high blood sugar; some mention leaking at the connection. Eleven reports describe injuries and no deaths were reported. No recalls name this device. In the past 12 months there were 8 reports, up from 1 in the previous 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 70
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 05705244006690), received between Dec 20, 2018 and Aug 26, 2026 — classified as 11 injuries, 59 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (52 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component52
- Material Twisted/Bent13
- Adverse Event Without Identified Device or Use Problem5
- Leak/Splash2
- Appropriate Device Problem Term/Code Not Available1
- Complete Blockage1
- Connection Problem1
- Loss of or Failure to Bond1
Patient problems
- No Known Impact Or Consequence To Patient35
- Hyperglycemia18
- No Clinical Signs, Symptoms or Conditions12
- Elevated Ketones/ Diabetic Ketoacidosis3
- Blood Loss1
- Hypoglycemia1
Recent adverse event reports
The 25 most recent of 70 reports, in the reporter's own words as published by the FDA.
InjuryAug 26, 2026Appropriate Device Problem Term/Code Not Available
It was reported that the patient experienced high blood glucose due to a possible infusion set occlusion on (b)(6) 2026. The event was treated with manual insulin injections.
Patient problems: Hyperglycemia
MAUDE report 50445717 ↗InjuryAug 25, 2026Material Twisted/Bent
It was reported that the patient had experienced high blood glucose level event on (b)(6) 2026 and the patient was treated with insulin pen.
Patient problems: Hyperglycemia
MAUDE report 50435119 ↗InjuryAug 24, 2026Material Twisted/Bent
It was reported that the patient had experienced high blood glucose level event on (b)(6) 2026 and the patient was treated with insulin pen.
Patient problems: Hyperglycemia
MAUDE report 50408948 ↗InjuryAug 24, 2026Material Twisted/Bent
Patient problems: Hyperglycemia
MAUDE report 50408739 ↗InjuryAug 24, 2026Material Twisted/Bent
It was reported that the patient had experienced high blood glucose level event on (b)(6) 2026 and the patient was treated with insulin pen.
Patient problems: Hyperglycemia
MAUDE report 50408716 ↗InjuryAug 24, 2026Material Twisted/Bent
It was reported that the patient had experienced high blood glucose level event on (b)(6) 2026 and the patient was treated with insulin pen.
Patient problems: Hyperglycemia
MAUDE report 50408708 ↗InjuryAug 24, 2026Material Twisted/Bent
It was reported that the patient had experienced high blood glucose level event on (b)(6) 2026 and the patient was treated with insulin pen.
Patient problems: Hyperglycemia
MAUDE report 50408704 ↗InjuryAug 24, 2026Complete Blockage; Material Twisted/Bent
It was reported that the patient experienced infusion set bent cannula causing high blood glucose and it was corrected by corrective bolus via insulin pen event on (b)(6) 2026.
Patient problems: Hyperglycemia
MAUDE report 50406454 ↗InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REFERENCE NUMBER (B)(4) EVENT OCCURRED IN MEXICO. IT WAS REPORTED THAT THE PATIENT WENT TO AN EMERGENCY ROOM (ER) AND EVENTUALLY GOT HOSPITALIZED ON (B)(6) 2025 DUE TO HYPERGLYCEMIA EVENT. BLOOD GLUCOSE LEVEL WAS MORE THAN 400 MG/DL AT THE TIME OF THE EVENT AND GOT TREATED WITH INSULIN VIA PUMP AND SERUM. THE DURATION OF HOSPITALIZATION WAS LESS THAN 24 HOURS. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis
MAUDE report 23422613 ↗MalfunctionSep 30, 2024Leak/Splash; Leak/Splash
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE PATIENT FACED AN EVENT OF LEAKAGE IN THE TUBING OR AT QUICK RELEASE ON (B)(6) 2024. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20331933 ↗MalfunctionJun 7, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT THE PATIENT FACED AN ISSUE WITH INFUSION SET CANNULA WAS BENT. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488384 ↗MalfunctionJun 6, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET CANNULA BENT EVENTS ON (B)(6) 2024. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19474394 ↗MalfunctionJun 6, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET CANNULA BENT EVENTS ON 03-MAY-2024. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19474392 ↗MalfunctionMay 27, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET CANNULA BENT EVENTS ON (B)(6) 2024. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19400565 ↗MalfunctionMay 22, 2024Material Twisted/Bent; Material Twisted/Bent
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CHINA. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT HE FOUND BENT CANNULA AFTER REMOVAL FROM THE INSERTION SITE. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369127 ↗MalfunctionMay 21, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE SAUDIA ARABIA. ON (B)(6) 2024, THE PATIENT'S MOTHER REPORTED THAT HER CHILD'S INFUSION SET FELL OFF DUE TO TAPE NOT STICKING ON THIRD DAY OF INSERTION ON THE THIGH AS SITE LOCATION. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19357118 ↗MalfunctionFeb 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON (B)(6) 2022, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET'S TUBING HAD DETACHED AT THE QUICK RELEASE. HOWEVER, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS NORMAL, SO NO MEDICAL TREATMENT WAS REQUIRED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13439739 ↗MalfunctionNov 18, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
ON 18-FEB-2022: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE THE AWARENESS DATE. MOREOVER, THE RESULT OF THE (COMPLAINT INVESTIGATION) OF RETURNED USED (1 TUBING), THE TUBING WAS RETURNED WITH DAMAGES (CUT). BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2021, THE PATIENT'S INFUSION SET'S TUBING TORN OFF ABOUT 18 HOURS AFTER USING THE SET. THE INSERTION SITE WAS PATIENT'S RIGHT THIGH, AND THIS INFUSION SET WAS THE FIRST ONE FROM THE BOX. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12834253 ↗MalfunctionApr 9, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem
ON 12-MAY-2021: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE THE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 SET) SHOWED THAT ALL THE TEST RESULTS WERE WITHIN SPECIFICATION. BASED ON THE RESULT: MEDICAL DEVICE PROBLEM CODE, COMPONENT CODE, TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2021, IT WAS REPORTED THAT THE PATIENT'S INFUSION SET, AND TUBE PART WAS BROKEN, AND INSULIN LEAKED. REPORTEDLY, THE PATIENT WAS HOSPITALIZED AT THE HOSPITAL WHEN THIS EVENT OCCURRED. THE PATIENT REPLACED THE INFUSION SET ON (B)(6) 2021. DURING THAT TIME, SHE HAD USED IT WITHOUT PROBLEMS, AND SHE DID NOT REMEMBER GETTING IT CAUGHT OR DROPPED. THERE WAS NO ZIPPER ON THE POUCH TO PUT THE PUMP IN, AND IT WAS NOT PINCHED. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11639708 ↗MalfunctionMar 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT THE PATIENT EXPERIENCED HIGH BLOOD GLUCOSE LEVEL DUE TO INFUSION SET'S TUBING DETACHMENT AS THE PATIENT NOTICE A SMELL OF INSULIN. MOREOVER, THE CATHETER WAS IN PLACE FROM PAST TWO DAYS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11548542 ↗MalfunctionJan 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IT WAS REPORTED THAT PATIENT'S NEW INFUSION SET'S TUBING DISCONNECTED AT THE TUBING CONNECTOR. PATIENT'S BLOOD GLUCOSE LEVEL WAS NORMAL. THEREFORE THE PATIENT DID NOT REQUIRE MEDICAL TREATMENT. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11249263 ↗MalfunctionDec 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER: (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED THAT THE INFUSION SET'S TUBING CAME OUT AT THE QUICK RELEASE AND THE PATIENT WOKE UP WITH BLOOD GLUCOSE LEVEL OF 540 MG/DL. THE PATIENT STATED THAT THIS ISSUE OCCURRED MAYBE FIVE TIMES IN 20 YEARS. UPON INVESTIGATION PERFORMED ON THE RETURNED USED DEVICE (1 USED SET), IT WAS FOUND THAT THE TUBING DETACHED FROM THE TUBING CONNECTOR. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 11053746 ↗MalfunctionOct 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
ON 21-DEC-2020: FOLLOW UP INFORMATION WAS SUBMITTED TO UPDATE AWARENESS DATE AND THE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICE (1 TUBING) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: TYPE OF INVESTIGATION CODE, INVESTIGATION FINDINGS CODE AND INVESTIGATION CONCLUSIONS CODE WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2020, IT WAS REPORTED THAT WHEN THE PATIENT WOKE UP, THE INFUSION SET'S TUBING CAME OUT OF THE CAP WHERE CONNECTED TO THE SITE CONNECTOR/ QUICK RELEASE PORTION WHILE SHE WAS SLEEPING AND HER BLOOD GLUCOSE LEVEL WAS 470MG/DL. THE SITE LOCATION WAS PATIENT'S THIGH AND THE PUMP WAS LOCATED NEXT TO HER. REPORTEDLY, THE INFUSIONS WERE NOT STORED, OR USED, IN A PLACE WHERE THEY MIGHT HAVE BEEN EXPOSED TO EXTREME TEMPERATURES AND HUMIDITY. THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: Hyperglycemia
MAUDE report 10668825 ↗MalfunctionJun 2, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT'S INFUSION SET TUBING DETACHED AT THE QUICK RELEASE. REPORTEDLY, IN TWO OUT OF TEN INFUSION SETS, THE CAP DID NOT LOCK AND ONE OF THEM CAME OFF, THE OTHER ONE DID NOT NEED TO BE SQUEEZED TO BE REMOVED. MOREOVER, WHEN SHE PUTS IT ON, IT SEEMS TO BE LOCKED IN PLACE. THE INFUSION HAD BEEN USED FOR ONE DAY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10108668 ↗MalfunctionDec 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
ON 11-MAR-2020: FOLLOW UP INFORMATION WAS SUBMITTED BECAUSE RESULT OF COMPLAINT INVESTIGATION OF THE RETURNED USED DEVICES (1 TUBING AND 1 CANNULA) SHOWED THAT THE TUBING WAS DETACHED FROM THE TUBING CONNECTOR. BASED ON THE RESULT: METHOD, RESULT AND CONCLUSION CODES WERE UPDATED. UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). IN THE MORNING OF (B)(6) 2019, THE PATIENT REPORTED THAT LAST NIGHT AT 3:00 AM, THE INFUSION SET'S TUBING BECAME DISCONNECTED FROM THE BODY AT THE TUBING PORTING WHILE SLEEPING. REPORTEDLY, THE SITE LOCATION WAS THE PATIENT'S ARM AND THE PUMP WAS ON THE BRA OR THE SHIRT. THE INFUSION HAD BEEN USED SINCE YESTERDAY ((B)(6) 2019). MOREOVER, THE INFUSIONS WERE STORED IN THE KITCHEN. THERE WAS NO STRESS OR PULL ON THE TUBING AND THE PUMP WAS NOT DROPPED WITH THE SET CONNECTED TO THE PATIENT'S BODY. NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9449088 ↗
Other Set, Administration, Intravascular devices
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- Autosoft90™ 1002817Unomedical A/S · Set, Administration, Intravascular1 recall11,907 reports
- Minimed™ Quick-set™ MMT-399AUnomedical A/S · Set, Administration, Intravascular9 deaths8,669 reports
- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
- MiniMed™ Mio™ Advance MMT-242AUnomedical A/S · Set, Administration, Intravascular15 deaths8,164 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.