Paradigm® REAL-Time Revel™ MMT-523NAS (UDI 00643169507203)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,259 adverse event reports that list this exact device (DI 00643169507203), received between Jun 2, 2017 and Oct 5, 2020 — classified as 9 deaths, 420 injuries, 830 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (292 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 1,259 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 5, 2020Patient Device Interaction Problem; Intermittent Communication Failure; Patient Device Interaction Problem; Intermittent Communication Failure

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. 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 10625093 ↗
• MalfunctionSep 11, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MED INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL, INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD AND DECLINED MOTOR POSITION ENCODER ERROR ALERT. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWOUND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10519626 ↗
• MalfunctionAug 25, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD RIM OF RESERVOIR COMPARTMENT BROKE OFF AND ALSO NO DELIVERY ALERTS. 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 10446933 ↗
• MalfunctionAug 11, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S ACT BUTTON WAS HARDER TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. INSULIN PUMP MOTOR SOUND WAS LABORED OR GRINDING. INSULIN PUMP HAD SCRATCHES. IT WAS HARDER FOR LIGHT TO TURN. 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 10389642 ↗
• MalfunctionAug 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS SCRATCHED AND HINDERS THE ABILITY TO USE. CUSTOMER STATED THAT THE RESERVOIR WAS WOBBLY AND LOOSE. 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 10389381 ↗
• MalfunctionAug 10, 2020Connection Problem; Connection Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS NOT LOCKING IN PLACE. 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 10384379 ↗
• MalfunctionAug 7, 2020No Display/Image; Mechanical Problem; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND ALSO DID NOT POWER ON. CUSTOMER STATED INSULIN PUMP HAD CRACK STARTING FROM THE BATTERY COMPARTMENT ENTRY. 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 10377585 ↗
• MalfunctionAug 6, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR COMPARTMENT WAS CHIPPED. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. 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 10372840 ↗
• MalfunctionAug 6, 2020Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem; Failure to Cycle; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DROPPED SOFT, RECEIVED COMPROMISED FORCED SYSTEM ERROR ALARM AND THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 10371800 ↗
• MalfunctionAug 5, 2020Moisture or Humidity Problem; Patient Device Interaction Problem; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS FOGGING UP AND HARD TO SEE. 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 10365991 ↗
• MalfunctionAug 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MED INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL, INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD AND DECLINED MOTOR POSITION ENCODER ERROR ALERT. CUSTOMER WAS UNABLE TO CLEAR THE ALARM ALSO NOT ABLE TO REWOUND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10360838 ↗
• MalfunctionJul 30, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT TURNING ON. THE CUSTOMER STATED CONTACTS ON BATTERY CAP WAS NOT DAMAGED. THE CUSTOMER STATED DISPLAY DID NOT RETURNED. 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 10343266 ↗
• InjuryJul 29, 2020Device Alarm System; No Display/Image; No Apparent Adverse Event; Device Alarm System; No Display/Image; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 900 MG/DL. THE CUSTOMER WENT TO EMERGENCY ROOM AND THEN WAS FLOWN TO HOSPITAL AND THEY HAD A STROKE WHILE IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED FOR ONE WEEK. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT WORKING AND WAS BEEPING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Stroke/CVA

  MAUDE report 10336682 ↗
• InjuryJul 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER REQUIRING AMBULANCE DUE TO LOW BLOOD GLUCOSE ON UNKNOWN DATE WITH BLOOD GLUCOSE OF BELOW 18 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10331151 ↗
• MalfunctionJul 27, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THAT INSULIN PUMP 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 10325566 ↗
• MalfunctionJul 24, 2020Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN AND MAKING IT HARD TO SEE. CUSTOMER STATED THEY WERE GETTING UNEXPLAINED NO DELIVERY ALARM AND PRIME AND REWIND PROCESS TAKES LONGER. 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 10318729 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT UP AND DOWN ARROW WAS FADING. CUSTOMER STATED THAT REWIND WAS LITTLE SLOWER AND LOUDER. 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 10307854 ↗
• MalfunctionJul 21, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ONCE OR TWICE BEFORE. THE CUSTOMER STATED THAT INSULIN PUMP REJECTS 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 10300467 ↗
• MalfunctionJul 21, 2020Display or Visual Feedback Problem; Obstruction of Flow; Priming Problem; Display or Visual Feedback Problem; Obstruction of Flow; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS CLOUDY. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. INSULIN PUMP PRIMING WAS LOUDER. 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 10300392 ↗
• MalfunctionJul 20, 2020Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SMUDGE ON SCREEN CAUSING IT HARD TO READ. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD REJECTED NEW BATTERY AND HAD UNEXPLAINED NO DELIVERY ALERTS NOT DUE TO SITE ISSUES. 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 10294218 ↗
• MalfunctionJul 17, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCED SENSOR SYSTEM ERROR ALARM DURING PRIMING. 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 10287631 ↗
• InjuryJul 16, 2020Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event; Mechanical Problem; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 464 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE CUSTOMER WAS UNSURE ABOUT THE DRIVE SUPPORT CAP DAMAGE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10282415 ↗
• MalfunctionJul 16, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. 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 10281920 ↗
• MalfunctionJul 14, 2020Display or Visual Feedback Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD INTERNAL DAMAGE ON THE SCREEN AND IT WAS HARD TO READ THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP HAD CRACKED NEAR THE RESERVOIR OPENING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10269706 ↗
• MalfunctionJul 13, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STOPPED WORKING. 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 10262773 ↗

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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-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