Paradigm® REAL-Time Revel™ MMT-723NAH (UDI 00643169077706)Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00643169077706), received between Jun 5, 2017 and Oct 9, 2020 — classified as 1 death, 22 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (15 reports).

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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• DeathOct 9, 2020Corroded

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS UNKNOWN. THE CALLER DID NOT KNOW IF THE CUSTOMER HAD ANY OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE ORIGINAL OWNER OF THE PUMP HAD PASSED AND THE PUMP WAS GIFTED TO THE CALLER. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THIS REPORT WAS CREATED FOR THE ANALYSIS RESULTS. THE KEYPAD WAS INSPECTED AND THE INTERMITTENT BUTTON RESPONSE WAS DUE TO CORRODED KEYPAD TRACES.

  Patient problems: Death

  MAUDE report 10659747 ↗
• MalfunctionDec 4, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR AND STOPPED DELIVERING INSULIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9414405 ↗
• InjuryNov 26, 2019Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  THE CLINICAL REPRESENTATIVE REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND DIABETIC KETOACIDOSIS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH INSULIN SHOTS. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD MOTOR ERROR WHICH STOPPED THE INSULIN PUMP COMPLETELY. IT WAS REPORTED THAT OVER THE PAST FEW MONTH THE CUSTOMER HAD TO CHANGE THE BATTERIES MUCH MORE OFTEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9375093 ↗
• MalfunctionSep 24, 2019No Apparent Adverse Event; No Apparent Adverse Event

  MEDTRONIC LEGAL DOCUMENT RECEIVED INFORMATION REGARDING THE FOLLOWING DEVICES WERE OR MAY BE THE SUBJECT OF LITIGATION. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INFORMATION LEGAL DOCUMENT ON (B)(6) 2019 STATED THE FOLLOWING DEVICE UNDER THIS LEGAL HOLD MIGHT NOT BE DESTRUCTIVELY ANALYZED WITHOUT WRITTEN APPROVAL FROM THE CORPORATE LITIGATION DEPARTMENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9108005 ↗
• MalfunctionSep 4, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 310 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8960301 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8844584 ↗
• MalfunctionJul 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WAS STUCK AND IT KEEP SCROLLING THROUGH THE NUMBERS. THE CUSTOMER¿S BLOOD GLUCOSE UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8763389 ↗
• MalfunctionJun 4, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 215 MG/DL. THE CUSTOMER REPORTED THAT SHE HAD TO PRESS BUTTONS MULTIPLE TIMES. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8665793 ↗
• MalfunctionMay 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE LITTLE STICKY. BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8631238 ↗
• MalfunctionApr 2, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 215 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475329 ↗
• MalfunctionMar 7, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE UP BUTTON WAS NOT WORKING ANYMORE. CUSTOMER¿S BLOOD GLUCOSE WAS 250 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398288 ↗
• MalfunctionJan 15, 2019Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THERE WAS DAMAGE ON THE BACK AND BATTERY COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP IS NOT ABLE TO WORK BECAUSE THE BATTERY CAP IS MISSING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8247102 ↗
• InjuryDec 28, 2018Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 501 MG/DL. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM AND CHANGED THE BATTERY AND WAS NOT ABLE TO REWIND. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8202832 ↗
• InjuryDec 11, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO KETOACIDOSIS AND HIGH BLOOD GLUCOSE WITH BLOOD GLUCOSE OF 407 MG/DL, CURRENT BLOOD GLUCOSE WAS 366 MG/DL. TIME AND DATE OF HOSPITALIZATION WAS (B)(6) 2018 ON 12 PM. ASSISTED WITH PERFORMING THE HP TEST AND TEST RESULTS DID NOT ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8149959 ↗
• MalfunctionNov 28, 2018Moisture or Humidity Problem; Patient Device Interaction Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE TOP AND BOTTOM OF INSULIN PUMP WAS CRACKED AND INSULIN PUMP WAS ALSO EXPOSED TO MOISTURE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8109807 ↗
• InjuryNov 2, 2018Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS FLUSH. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8031650 ↗
• MalfunctionOct 12, 2018Priming Problem; Priming Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DOES NOT PUSH INSULIN THOUGH THE TUBING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7962404 ↗
• MalfunctionOct 3, 2018Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE DRIVE SUPPORT CAP WAS OFF. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 93 MG/DL. THE CUSTOMER EXPERIENCED VOMITING. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Vomiting

  MAUDE report 7932578 ↗
• MalfunctionSep 26, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD SQUIRTED INSULIN WHEN SHE PRIMES THE CLOCK TIME DOES NOT KEEP UP. THE CUSTOMER¿S BLOOD GLUCOSE WAS BETWEEN 73 MG/DL TO 300 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD A VERTICAL CRACK. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7913111 ↗
• MalfunctionSep 7, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD PRIME ANOMALY. THE PATIENT¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS DAMAGED AND THE INSULIN WAS SQUIRTING OUT INSULIN WHILE PRIMING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7858335 ↗
• InjuryAug 16, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 482 MG/DL. DURING TROUBLESHOOTING, THE CUSTOMER WAS INSTRUCTED TO INSERT A NEW BATTERY AND THE CUSTOMER DID NOT RECEIVE AN ALARM. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH READING. THE CUSTOMER WAS ADVISED THAT THEY WOULD BE GETTING A REPLACEMENT BATTERY CAP. NO PRODUCT WILL RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7792212 ↗
• InjuryMay 31, 2018Loose or Intermittent Connection; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE INSULIN PUMP HAD COMPRISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 184 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATE THAT DRIVE SUPPORT CAP WAS LOOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7557216 ↗
• MalfunctionMay 25, 2018Excess Flow or Over-Infusion

  THE HEALTH CARE PROFESSIONAL REPORTED VIA PHONE CALL THAT INSULIN PUMP GOT THE OVER DELIVERY. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7544191 ↗
• MalfunctionMay 14, 2018Low Battery; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND POWER ERROR AND LOW BATTERY ALERTS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7510184 ↗
• MalfunctionApr 18, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP RECEIVED AN UNEXPECTED RESTART ERROR AND BUTTON ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATES WAS TAKING A SHOWER AND WHEN THEY CAME OUT THE PUMP RECEIVED AN UNEXPECTED RESTART ERROR ALARM. THE CUSTOMER ALSO REPORTED PUMP ERROR DUE TO REPLACING THE BATTERY. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7440888 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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