Paradigm® REAL-Time Revel™ MMT-523LNAP (UDI 00643169513853)Recalls & reported problems

Summary

The FDA's MAUDE database contains 597 adverse event reports that list this exact device (DI 00643169513853), received between May 3, 2017 and Aug 10, 2020 — classified as 2 deaths, 286 injuries, 309 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (86 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 597 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM AND COMPLETE PUMP REWIND. CUSTOMER DID NOT REPORT AN MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM. 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 10383894 ↗
• MalfunctionAug 7, 2020Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER REPORTED THAT THE INSULIN WAS STUCK AT 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 10377516 ↗
• MalfunctionAug 6, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY SCREEN. THE CUSTOMER ALSO STATED THAT, THE DISPLAY DID NOT RETURN AFTER PUMP RESTART. THE CUSTOMER WAS NOT ABLE TO COMPLETE SELF TEST CUSTOMER GOT ANOTHER FAILED BATTERY TEST CUSTOMER THINKS ISSUES WAS WITH HER BATTERIES. THE CUSTOMER GOT A LOW BATTERY HAS TRIED TO CHANGE BATTERY AND GETTING NO RESPONSE. 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 10372045 ↗
• MalfunctionAug 3, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCED SENSOR ALARM DURING FILL TUNING. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS NOTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10355661 ↗
• MalfunctionJul 21, 2020Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. INSULIN WAS SQUIRTS. 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 10301131 ↗
• MalfunctionJul 7, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC A THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS, ESC BUTTON WAS HARDER TO PRESS AND DIMINISHED BATTERY LIFE. NO HARM A MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10238201 ↗
• MalfunctionJun 19, 2020Device Difficult to Program or Calibrate; Material Integrity Problem; Device Difficult to Program or Calibrate; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT OR ESCAPE KEYS WERE NOT RESPONDING. CUSTOMER STATED THAT THE TIME WAS ADVANCING. CUSTOMER WAS UNABLE TO REMOVE BATTERY CAP. 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 10174247 ↗
• MalfunctionJun 12, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON ON THE INSULIN PUMP WAS STICKING. CUSTOMER STATED THAT THE TIME WAS ADVANCING. 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 10147760 ↗
• MalfunctionJun 10, 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 WAS PROTRUDED AND LOOSE. CUSTOMER STATES THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. 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 10136660 ↗
• MalfunctionJun 9, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR AND BUTTON HARD TO PRESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10136535 ↗
• InjuryJun 9, 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 WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2020 WITH THE BLOOD GLUCOSE LEVEL OF 899 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. CUSTOMER WAS TREATED WITH INSULIN DRIP. CUSTOMER DID NOT ALLEGE THAT THE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10131742 ↗
• MalfunctionJun 1, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PIECE OF THE RESERVOIR COMPARTMENT WAS MISSING AND THE RESERVOIR WAS NOT ABLE TO LOCK 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 10105766 ↗
• InjuryMay 20, 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 HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 417 MG/DL AT THE TIME OF INCIDENT AND ANOTHER BLOOD GLUCOSE LEVEL WAS 260 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10073938 ↗
• MalfunctionMay 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE UNRESPONSIVE. 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 10041932 ↗
• MalfunctionApr 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE LESS RESPONSIVE. 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 10008343 ↗
• MalfunctionApr 28, 2020Display or Visual Feedback Problem; Priming Problem; Display or Visual Feedback Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS PRIMING AND HAD RAINBOW EFFECT ON THE SCREEN. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THEY HAD CONTACTED THEIR HEALTH CARE PROFESSIONAL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF LOW BLOOD GLUCOSE LEVEL. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10003799 ↗
• MalfunctionApr 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK ON RESERVOIR COMPARTMENT. CUSTOMER STATED RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 9999922 ↗
• MalfunctionApr 23, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND UNABLE TO REWIND THE INSULIN PUMP. 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 9993374 ↗
• MalfunctionApr 21, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE KEYPAD ON THE INSULIN PUMP WAS NOT GOING ANYWHERE AND NOT MOVING. CUSTOMER STATED THAT THE TIME WAS ADVANCING. 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 9984470 ↗
• MalfunctionApr 21, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WERE SCRATCHES ON THE SCREEN, WAS PRESSING HARDER ON THE BUTTONS TO RESPOND, THERE WAS A CRACK ON THE INSULIN PUMP BY THE RESERVOIR, THERE WAS GRINDING NOISE FROM THE PISTON WHEN PRIMING AND HAD NO DELIVERY ALARMS. 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 9980154 ↗
• MalfunctionApr 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS CRACKED AROUND THE TOP OF THE RESERVOIR COMPARTMENT AND O RING WAS LOOSED. THE CUSTOMER STATED THAT THE RESERVOIR WAS LOCKED INTO PLACE. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9951150 ↗
• MalfunctionApr 6, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD FROZEN SCREEN AND ALSO HAD BATTERY OUT LIMIT ALARM DURING NORMAL USE. CUSTOMER REPORTED THAT THEY WERE UNABLE TO CLEAR THE 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 9927599 ↗
• MalfunctionMar 25, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD A CRACKED DISPLAY SCREEN, THE INSULIN PUMP HAD A WEAK BACKLIGHT, GAVE BUTTON AND M ERROR CODE ALARMS, AND SOMETIMES THE BUTTONS WERE HARD TO PRESS AND THE PUMP WOULD TAKE LONGER TO REWIND. THE CUSTOMER'S DECLINED TO PROVIDE THEIR BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT. THE CUSTOMER DECLINED TROUBLESHOOTING. NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9881770 ↗
• MalfunctionMar 23, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE ALARM OCCURRED SHORTLY AFTER TROUBLESHOOTING AND INSERTING A NEW BATTERY. 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 9864479 ↗
• InjuryMar 18, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 500 MG/DL AT TIME OF INCIDENT. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT AND AUTO MODE WAS ACTIVE. CUSTOMER TREATED WITH INJECTION. CUSTOMER DOES NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM AND NO LONGER WORKING. CUSTOMER OBSERVE TIME CLOCK FOR ONE MINUTE AND TIME WAS ADVANCES. THE INSULIN PUMP WILL RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9847044 ↗

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