Paradigm® REAL-Time Revel™ MMT-723LNAB (UDI 00613994748850)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994748850), received between Sep 26, 2017 and Nov 30, 2018 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (1 report).

14 other recalls cover devices cleared under the same FDA submission (P980022); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 30, 2018Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED AND DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2018. THE CUSTOMER¿S BLOOD GLUCOSE WAS 800 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS. IT WAS REPORTED THAT THEY HAD VOMITING. THE CUSTOMER REPORTED THAT THEY HAD KEYPAD ISSUES AND BUTTONS WERE NOT RESPONDING. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS FROZEN. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8119126 ↗
• DeathMay 7, 2018Defective Component

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN A HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2017. THE CAUSE OF DEATH WAS HEART FAILURE. THE CALLER STATED THAT THE CUSTOMER HAD ARTHRITIS THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE PUMP HAD BEEN DISCONNECTED MORE THAN 48 HOURS PRIOR TO PASSING, AS THE NURSES USED MANUAL INJECTIONS ON THE CUSTOMER. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THE PUMP WAS RECEIVED WITH A FLUSH DRIVE SUPPORT CAP.

  Patient problems: Death

  MAUDE report 7491449 ↗
• InjuryOct 5, 2017High Readings

  THE POS TECH REPORTED FOR THE CUSTOMER VIA PHONE CALL THAT THE PATIENT WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE PATIENT¿S CURRENT GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6915955 ↗
• MalfunctionSep 26, 2017Device Inoperable; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD FINISH LOADING ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 144 MG/DL. CUSTOMER STATES THEY WERE REFILLING RESERVOIR AND HE WAS TRYING TO FILL THE TUBING AND THERE WAS NO INSULIN GOING THROUGH THE ACT BUTTON WAS NOT WORKING OR THE PUMP WASN'T WORKING TO PUSH OUT ANY INSULIN. CUSTOMER STATES THE TIME IS CORRECT ON THE PUMP IS ABLE TO USE THE BUTTON BUT IT WILL NOT MOVE FROM THE LOAD RESERVOIR SCREEN. CUSTOMER IS NOT ABLE TO CLEAR THE ALARM. ADVISED CLEARING THE ALARM RESUMES CURRENT BASAL DELIVERY. FINISH LOADING ALARM OCCURRED. ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6894611 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P980022. One submission often covers many models, so check the product and lot details in each record.

• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1256-2025 · Jan 31, 2025 · Open, Classified
  Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-2442-2015 · Jul 22, 2015 · Terminated
  Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with d
• Z-2179-2014 · Jul 21, 2014 · Terminated
  Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K Product Usage: The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combinatio
• Z-2544-2014 · Mar 13, 2014 · Terminated
  Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K