Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00643169507197)Recalls & reported problems

Summary

The FDA's MAUDE database contains 553 adverse event reports that list this exact device (DI 00643169507197), received between May 30, 2017 and Aug 10, 2020 — classified as 187 injuries, 366 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (104 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 553 reports, in the reporter's own words as published by the FDA.

• InjuryAug 10, 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 HAD A HIGH BLOOD GLUCOSE VALUE OF 523 MG/DL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10383572 ↗
• InjuryAug 6, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD NO DELIVERY ALARM DURING BOLUSES, EVENT WAS RESOLVED BY COMPLETE SET CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10371895 ↗
• MalfunctionAug 4, 2020No Display/Image; Overheating of Device; Patient Device Interaction Problem; No Display/Image; Overheating of Device; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN BECAME COMPLETELY DARK WHEN HOTTHE CUSTOMER ALSO SATETD THAT, THE THERE WERE HAIRLINE CRACK BELOW ESCAPE BUTTON TO RESERVOIR WINDOW AND RESERVOIR COMPARTMENT WORN PIECES FALLING OFF. 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 10362401 ↗
• InjuryAug 3, 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 BLOOD GLUCOSE UNKNOWN. THE CUSTOMER WAS TREATED WITH INTRAVENOUS. CUSTOMER WAS EXPERIENCED SYMPTOMS LIKE FLU. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10355836 ↗
• MalfunctionJul 28, 2020Device Alarm System; Power Problem; Device Alarm System; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS RAN OUT OF INSULIN WITHOUT WARNING. CUSTOMER ALSO REPORTED THAT INSULIN PUMP WAS REJECTING 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 10330858 ↗
• MalfunctionJul 27, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RAN OUT OF INSULIN WITHOUT WARNING. CUSTOMER ALSO REPORTED THAT INSULIN PUMP WAS REJECTING 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 10325129 ↗
• MalfunctionJul 24, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND ALSO INSULIN PUMP WAS STOPPED WORKING. CUSTOMER STATED DRIVE SUPPORT CAP APPEARS NORMAL. 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 10320657 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR SENSOR TEST FAILURE. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND UNABLE TO COMPLETE REWIND. CUSTOMER WAS PERFORMED DISPLACEMENT TEST AND IT WAS FAILED. 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 10294512 ↗
• MalfunctionJul 16, 2020Mechanical Problem; Mechanical Problem

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

  Patient problems: Hyperglycemia

  MAUDE report 10281823 ↗
• MalfunctionJul 6, 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 DURING PRIMING. 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 10233072 ↗
• InjuryJul 6, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 597 MG/DL. CUSTOMER STATED THEY HAD NO DELIVERY ALARMS AND OTHER ALARMS. CUSTOMER STATED THAT WAS PRIMING HER TUBING WHEN SHE GOT THE NO DELIVERY ALARM. CUSTOMER STATED THAT HAS TRIED DIFFERENT CANNULA LENGTHS. CUSTOMER STATED THEY HAVE TRIED ALL REMEDIES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10232364 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 597 MG/DL. CUSTOMER HAD DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10231403 ↗
• MalfunctionJul 1, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE AT TIMES. CUSTOMER REPORTED BUTTONS WERE STICKY AND HARD TO PRESS. CUSTOMER ALSO REPORTED THAT BATTERY LIFE WAS DIMINISHED. 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 10217556 ↗
• MalfunctionJul 1, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM HOWEVER, INSULIN EXITED AFTER NO DELIVERY TROUBLESHOOTING. CUSTOMER DECLINED TO FURTHER TROUBLESHOOTING. 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 10217241 ↗
• InjuryJun 30, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING LOW BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS IN RANGE OF 20 MG/DL. CUSTOMER STATED INSULIN PUMP HAD BUTTON ISSUE, NO DELIVERY ALARM, REWIND LOUDER, BATTERY LIFE WAS DIMINISHED. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10210725 ↗
• MalfunctionJun 25, 2020Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD RAINBOW EFFECT MAKING IT HARDER TO READ. CUSTOMER STATED INSULIN PUMP HAD REJECT NEW BATTERIES, HAIRLINE FRACTURE AT RESERVOIR SIDE, 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 10193541 ↗
• MalfunctionJun 24, 2020Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD STOPPED TO REWIND, SLOWER AND LOUDER TO REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER STATED THAT INSULIN PUMP WAS LOST SETTING DURING BATTERY CHANGE AND BATTERY LIFE DECREASED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10187633 ↗
• MalfunctionJun 19, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS 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 10174127 ↗
• MalfunctionJun 5, 2020Failure to Cycle; Detachment of Device or Device Component; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE INSULIN PUMP WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. 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 10122717 ↗
• MalfunctionJun 5, 2020Failure to Cycle; Moisture or Humidity Problem; Failure to Cycle; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DROPPED IN WATER AND HAD A COMPROMISED FORCE SENSOR SYSTEM 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 10121979 ↗
• 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 LOW BLOOD GLUCOSE OF 47 MG/DL. CUSTOMER¿S OTHER BLOOD GLUCOSE WAS 27 MG/DL,39 MG/DL,40 MG/DL,44 MG/DL. THE CUSTOMER TREATED WITH THE FOOD. TROUBLESHOOTING WAS DONE FOR LOW BLOOD GLUCOSE AND OVER DELIVERY. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS OVER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10117971 ↗
• MalfunctionMay 27, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM HOWEVER NOT ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091261 ↗
• MalfunctionMay 15, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP REJECTED NEW BATTERY, CRACK BY BATTERY AND RESERVOIR AREA. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10060175 ↗
• MalfunctionMay 13, 2020Battery Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Battery Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A UNEXPLAINED ERROR THAT CAUSED THE PUMP TO BECOME UNRESPONSIVE. CUSTOMER ALSO REPORTED BATTERY LIFE LASTING LESS THAN TWO WEEKS, TINY CRACKS ON THE DISPLAY, AND CRACK BY THE RESERVOIR WINDOW. CUSTOMER DECLINED TO PROVIDE BLOOD GLUCOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051255 ↗
• MalfunctionMay 12, 2020Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem; Date/Time-Related Software Problem; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REJECTED BRAND NEW BATTERIES, CLOCK WAS SLOW AT TIMES AND THE EDGE ALONE WHERE THE RESERVOIR PLACED WAS CRACKED AND HAD BEEN A PROBLEM. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10048549 ↗

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-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-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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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