Paradigm® REAL-Time Revel™ MMT-523LNAS (UDI 00643169513860)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,199 adverse event reports that list this exact device (DI 00643169513860), received between May 11, 2017 and Aug 13, 2020 — classified as 6 deaths, 527 injuries, 666 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (151 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 1,199 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10400257 ↗
• MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. 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 10395595 ↗
• MalfunctionJul 31, 2020Device Alarm System; No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Date/Time-Related Software Problem; Power Problem; Device Alarm System; No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Date/Time-Related Software Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD REJECTED BATTERIES, ON ONE OCCASION THE CLOCK LOST TIME AND SHOWED 12AM, ALARMS STARTED BEEPING EVEN THOUGH WERE SET FOR VIBRATIONS, IT GAVE RANDOM NO DELIVERY ALARMS, ON 3 OR 4 OCCASIONS THE WHOLE SCREEN SUDDENLY WENT BLACK, THE ACT BUTTON REQUIRED HARDER PUSH TO WORK AND THE INSULIN PUMP SOUNDED DIFFERENT WHILE REWINDING. 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 10349233 ↗
• MalfunctionJul 31, 2020Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCH ON THE SCREEN MAKING IT HARD TO READ. ALSO REPORTED NO DELIVERY ALARM WHICH WAS RESOLVED BY WAS RESOLVED BY CHANGING COMPLETE SET. 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 10348665 ↗
• MalfunctionJul 30, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. CUSTOMER STATED THE CONTACT ON THE BATTERY CAP WAS NOT MISSING OR DAMAGE OR CORRODED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE DISPLAY DID NOT RETURN AFTER INSULIN PUMP RESTART. 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 10342462 ↗
• MalfunctionJul 28, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON WAS NOT RESPONDING. CUSTOMER STATED THAT THE INSULIN PUMP HAD TO REWIND MORE THAN ONCE. CUSTOMER STATED THAT THE SCREEN WAS SCRATCHED. 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 10331532 ↗
• MalfunctionJul 26, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER STATED THAT THERE WAS CHIPPING NEAR RESERVOIR AREA. 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 10324595 ↗
• MalfunctionJul 23, 2020Premature Discharge of Battery; Loss of Data; Power Problem; Premature Discharge of Battery; Loss of Data; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP. THE CUSTOMER WAS REPORTED THAT THE ALARM WAS IMMEDIATELY OCCURRED AFTER BATTERY CHANGE. 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 10312989 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD TOP RIGHT HAND BUTTON WAS HARDER TO PUSH WHILE BOLUSING. 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 10275293 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE HARD TO PRESS. THE CUSTOMER ALSO STATED THAT THEY CHANGES BATTERIES EVERY TWO WEEKS, INSULIN PUMP REJECTS NEW BATTERIES DURING REPLACEMENT. 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 10274883 ↗
• InjuryJul 14, 2020Device 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 THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2016 WITH BLOOD GLUCOSE OF 1499 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS INSULIN. CUSTOMER WAS IN EMERGENCY MEDICAL SERVICE. CUSTOMER WAS IN COMA. CUSTOMER STATED THAT THERE WAS ISSUE WITH PUMP BUTTONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Coma; Hyperglycemia

  MAUDE report 10274292 ↗
• MalfunctionJul 10, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. CUSTOMER STATED THE ISSUE WAS NOT RESOLVED. 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 10257058 ↗
• MalfunctionJul 9, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. 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 10249975 ↗
• MalfunctionJul 9, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON HARD TO PUSHED. 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 10249005 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS IN THE RANGE OF 119 TO 500 MG/DL. THE CUSTOMER WAS TREATED WITH THE INSULIN PUMP. THE CUSTOMER BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10238602 ↗
• MalfunctionJul 7, 2020Power Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS NOT WORKING AND WENT OFF. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL FOR TWO MONTHS AND CURRENT BLOOD GLUCOSE LEVEL WAS 119 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10238507 ↗
• MalfunctionJul 3, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. CUSTOMER STATED BATTERY LASTING 2 WEEKS AND ALERTS WITH A COUNTDOWN. 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 10229376 ↗
• InjuryJun 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2020. THE CUSTOMER¿S BLOOD GLUCOSE WAS OVER 500 MG/DL AT THE TIME OF HOSPITALIZATION. HE CUSTOMER DID NOT EXPERIENCED SYMPTOMS DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN DRIP. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER STATED THAT THE THERE WERE NO ALARMS OR ALERTS ON THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN SET CANNULA BECAME BENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10206317 ↗
• MalfunctionJun 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDING. 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 10205314 ↗
• MalfunctionJun 17, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THE DRIVE SUPPORT CAP WAS NORMAL. 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 10161737 ↗
• InjuryJun 4, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS MORE THAN 400 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER DECLINED TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10118029 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 402 MG/DL AND 523 MG/DL. THE CUSTOMER TREATED WITH MANUAL BOLUS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10117800 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 402 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10117796 ↗
• InjuryJun 2, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING HIGH AND LOW BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL AND 30 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH AND LOW BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH 100 GRAMS OF CARBOHYDRATES. CUSTOMER WAS NEITHER IN EMERGENCY ROOM NOR ADMITTED INTO HOSPITAL. BASED ON CUSTOMER REPORT CUSTOMER DID ALLEGE INSULIN PUMP WAS OVER DELIVERING. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10107995 ↗
• MalfunctionJun 1, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DRIVE SUPPORT CAP APPEARS FLUSH. 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 10104498 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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