Paradigm® REAL-Time Revel™ MMT-723LNAH (UDI 00643169513884)Recalls & reported problems

Summary

The FDA's MAUDE database contains 961 adverse event reports that list this exact device (DI 00643169513884), received between May 18, 2017 and Oct 6, 2020 — classified as 4 deaths, 404 injuries, 553 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (147 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 961 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NO LONGER WORKING, IT DROPPED AND THE BOTTOM CAME OFF AND THE SIDE CRACKED AS WELL. CUSTOMER STATED THE RESERVOIR LIP RING DID NOT SHOW SIGNS OF DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10632861 ↗
• MalfunctionAug 10, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PRESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10383709 ↗
• InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT SOMETIME LAST YEAR THEY HAD 2 INSTANCES WHERE THEY REQUIRED EMERGENCY MEDICAL ASSISTANCE. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE DATES AND DETAILS OF THE EMERGENCY ROOM VISIT AND WAS NOT ABLE TO CONFIRM IF THEY WERE DUE TO THEIR BLOOD GLUCOSE. CUSTOMER STATED IN ONE OF THE HOSPITAL VISIT, THEY TOOK THE PUMP OFF AND SENT HER HOME WITH PENS. NO FURTHER DETAILS WERE GIVEN. NO PRODUCT IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10347523 ↗
• MalfunctionJul 23, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE STICKING WHEN PRESSED HAD CRACK. THE CUSTOMER STATED THAT INSULIN PUMP HAD RANDOM NO DELIVERY ALERTS AND IT REJECTED NEW BATTERIES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10313833 ↗
• MalfunctionJul 17, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON WAS HARD TO PRESS. ALSO THERE WAS CRACK ON THE BATTERY CAP AND WAS LOUD DURING REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10287669 ↗
• InjuryJul 8, 2020Communication or Transmission Problem; No Apparent Adverse Event; Communication or Transmission Problem; No Apparent Adverse Event

  THE CUSTOMER¿S MOTHER AND HUSBAND REPORTED THAT CUSTOMER WAS HOSPITALIZED DUE DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2020. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS OVER 404 MG/DL. CUSTOMER STATED THAT THEY WERE HOSPITALIZED DUE TO AN INSULIN PUMP MALFUNCTION. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT ALARM OR INDICATE AN ISSUE, CUSTOMER WENT TO BED AND WOKE UP VOMITING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER¿S HUSBAND TOOK CUSTOMER TO EMERGENCY ROOM AND WAS TREATED WITH INTRAVENOUS DRIP AND DEXTROSE AND SALINE ADMINISTRATION. CUSTOMER DOES NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss; Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Vomiting

  MAUDE report 10248838 ↗
• MalfunctionJul 8, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED DRIVE SUPPORT CAP WAS PROTRUDED. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243624 ↗
• MalfunctionJul 8, 2020Device Difficult to Program or Calibrate; Connection Problem; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Connection Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS LOOSENED AND RESERVOIR DOES NOT LOCK INTO PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER REPORTED FAILED BATTERY TEST AND SOMETIMES PUMP WOULD REJECT BRAND NEW BATTERIES WITH CRACK IN THE CASING NEAR THE TOP OF THE BATTERY COMPARTMENT. CUSTOMER STATED SOMETIMES THE UP BUTTONS HAD TO BE PRESSED TWICE BEFORE THE BUTTON WILL ACTIVATE AND 2 TINY SCRATCHES ON THE DISPLAY, DID NOT AFFECT READABILITY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243501 ↗
• MalfunctionJul 6, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN DRIPS OUT OF INFUSION SET WITH PRIMING, DIMINISHED BATTERY LIFE AND REWIND AND PRIME MAKES A GRINDING NOISE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10233556 ↗
• MalfunctionJul 2, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND INSULIN WAS SQUIRTED OUT DURING MANUAL PRIME PROCESS. CUSTOMER STATED INSULIN PUMP WAS NOT DROPPED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10223067 ↗
• MalfunctionJun 19, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Flow or Under Infusion; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER WAS REPORTED THAT THE INSULIN PUMP HAD CRACK AND NO DELIVERY ALERT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172802 ↗
• MalfunctionJun 19, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF THE INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10172450 ↗
• MalfunctionJun 18, 2020Mechanical Problem; Obstruction of Flow; Power Problem; Mechanical Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED INSULIN PUMP WAS UNABLE TO REWIND. CUSTOMER STATED INSULIN PUMP NOT RESPONDING AND GOT NO DELIVERY ALARMS. CUSTOMER REPORTED EVENT WAS RESOLVED BY CHANGING COMPLETE SET. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10166253 ↗
• MalfunctionJun 17, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO COMPLETE THE REWIND PROCESS BUT THE ERROR RECURRED. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARED NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10161466 ↗
• MalfunctionMay 25, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD AN ISSUE WITH UP ARROW ON THE INSULIN PUMP BEING UNRESPONSIVE. THE CUSTOMER ALSO STATED THAT THE TIME WAS ADVANCING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10085797 ↗
• MalfunctionMay 22, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE NOT RESPONSIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURN FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10082164 ↗
• MalfunctionMay 22, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE DELAY WHEN PRESSING. INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT WHEN PRIMING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10082125 ↗
• MalfunctionMay 22, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10081476 ↗
• InjuryMay 21, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 425 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED INSULIN PUMP WAS UNDER DELIVERING. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10078087 ↗
• MalfunctionMay 20, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT UNLOCKING AND COULD NOT REWIND. THE CUSTOMER ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVEL BUT DECLINED TROUBLESHOOTING AS THEY FELT OKAY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10074099 ↗
• MalfunctionMay 20, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SHOWING THE KEYPAD IS LOCKED AND COULD NOT PRESS THE B AND THE DOWN BUTTON AT THE SAME TIME TO GET IT UNLOCKED. CUSTOMER STATED THAT THE BUTTONS WERE TO HARD TO PUSH TO GET THE INSULIN PUMP TO RESPOND. THE CUSTOMER WAS UNABLE TO PRIME THE INSULIN PUMP AND CHANGE THE SET. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10074095 ↗
• MalfunctionMay 20, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SOMETIMES THE DOWN BUTTON WAS HARD TO PRESS ALSO CUSTOMER SMELLS THE INSULIN AND THEY DID NOT KNOW WHERE IT WAS CAME FROM. CUSTOMER ALSO STATED THAT BATTERY WAS LAST ONLY TWO TO THREE DAYS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10073600 ↗
• MalfunctionMay 18, 2020Premature Discharge of Battery; Loss of Data; Patient Device Interaction Problem; Premature Discharge of Battery; Loss of Data; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. A COLD RESET WAS PERFORMED AND EXTERNAL RAM CRC ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED A CRACK ON THE INSULIN PUMP ON THE BATTERY COMPARTMENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10064699 ↗
• MalfunctionMay 18, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE HARDER TO PRESS AND HAD TO PRESS MORE THAN ONCE TO GET WORK. CUSTOMER STATED THAT THE INSULIN PUMP WAS SLOWER DURING REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10064602 ↗
• MalfunctionMay 15, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED WITH MOTOR ERRORS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060752 ↗

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-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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