Paradigm® REAL-Time Revel™ MMT-523RNAS (UDI 00643169513099)Recalls & reported problems

Summary

The FDA's MAUDE database contains 897 adverse event reports that list this exact device (DI 00643169513099), received between May 6, 2017 and Apr 25, 2023 — classified as 8 deaths, 426 injuries, 463 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (130 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 897 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT RESERVOIR COMPARTMENT WAS BROKEN, AND THE TYPE OF DAMAGE WAS TOP PIECE THAT WAS BROKEN THAT HAD RUBBER RING WAS BROKEN, THE DAMAGE OCCURRED WHILE CHANGING RESERVOIR IT WENT TO UNSCREW IT AND IT JUST POPPED OFF. CUSTOMER ALSO REPORTED DAMAGE TO THE PUMP. IT WAS REPORTED THAT COMPARTMENT/LIP/RING THE RESERVOIR WAS STILL LOCK IN PLACE TO WHEN INSERTED INTO PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WILL DISCONTINUE TO USE THE INSULIN PUMP DUE TO DAMAGE AND PUMP WILL BE RETURNED FOR PRODUCT ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16804716 ↗
• MalfunctionJul 14, 2021Break; Mechanical Problem; Obstruction of Flow; Break; Mechanical Problem; Obstruction of Flow

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

  Patient problems: Insufficient Information

  MAUDE report 12168066 ↗
• MalfunctionAug 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BROKEN RESERVOIR COMPARTMENT, BROKEN ON TOP AND BROKE INTO THREE PIECES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THE RESERVOIR IS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10463576 ↗
• MalfunctionAug 26, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BACK SIDE OF THE BATTERY COMPARTMENT THREADING AND TOP OF THE RESERVOIR COMPARTMENT WAS CRACKED. IT WAS ALSO REPORTED THAT THEY RECEIVED NO DELIVERY ALARM AND EVENT WAS RESOLVED BY COMPLETE SET CHANGE. CUSTOMER STATED THERE WAS PHYSICAL DAMAGE TO RETAINER RING AND RESERVOIR WAS 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 10452399 ↗
• MalfunctionAug 11, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WAS HARD TO PRESS AND STICK. 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 10390341 ↗
• MalfunctionAug 10, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THE USER ALLEGED THE INSULIN PUMP WAS UNDER DELIVERING INSULIN AS THEY DELIVERED BOLUS BUT IT DID NOT COMING DOWN. CUSTOMER WAS TREATED WITH MANUAL INJECTION. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10384277 ↗
• MalfunctionAug 7, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE VERY HARD TO PRESS. 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 10378226 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM AND THE CUSTOMER WAS STUCK IN REWIND PROCESS. 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 10371425 ↗
• MalfunctionJul 29, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS NOT RESPONDING. INSULIN PUMP WAS INDICATING WACKY NUMBERS. 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 10337050 ↗
• MalfunctionJul 29, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER SELECTED ACTION BUTTON TO REWIND AND IT DID NOT REWIND THE INSULIN PUMP. THE SCREEN WENT BLANK. 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 10336870 ↗
• MalfunctionJul 24, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. CUSTOMER'S WIFE REPORTED THAT HER HUSBAND GOT AN INSULIN FLOW BLOCKED ALARM. WHILE TROUBLESHOOTING CUSTOMER'S CALLED GOT DISCONNECTED. 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 10318857 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR COMPARTMENT HAD CRACK. THE CUSTOMER STATED THAT THE RESERVOIR WAS 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 10313652 ↗
• MalfunctionJul 23, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR ALERT. 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 10313377 ↗
• MalfunctionJul 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP OF THE INSULIN PUMP WAS FLUSHED. CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 268 MG/DL AND WAS TREATED WITH INSULIN PUMP. HAD SYMPTOMS LIKE NAUSEA AND STOMACH ROLLS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Hyperglycemia; Nausea

  MAUDE report 10301190 ↗
• MalfunctionJul 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER RECEIVED AN UNSPECIFIED ALARM ON THE INSULIN PUMP. THE CUSTOMER DID NOT WANT TO TROUBLESHOOT IT AS, HE UNDERSTOOD THE 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 10294354 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEIR INSULIN PUMP'S ESCAPE BUTTON DID NOT WORK. CUSTOMER REPORTED THAT THEY RECEIVED MOTOR ERROR ALARM. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT RECEIVE MOTOR POSITION ENCODER ALARM. CUSTOMER STATED THE INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 10275607 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ACT BUTTON HAD DELAYED RESPONSE WHEN BEING PRESSED. CUSTOMER STATED TIME WAS ADVANCED. 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 10269116 ↗
• MalfunctionJul 13, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK RESERVOIR OPENING. THE CUSTOMER STATED THAT THE RESERVOIR DID NOT LOCK INTO 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 10264071 ↗
• InjuryJul 13, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. THE CUSTOMER REPORTED THAT ACT AND ESCAPE BUTTONS WERE NOT RESPONDING, BUTTONS WERE GETTING HARDER. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10262904 ↗
• InjuryJul 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. CUSTOMER WAS REPORTING ISSUES RELATED TO THE BUTTONS THEY ARE HARD TO MASH. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF INCIDENT. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, VOMITING. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THEY DID NOT ALLEGING INSULIN PUMP FOR UNDER DELIVERY. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTS THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10256393 ↗
• InjuryJul 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 ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 864 MG/DL. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL. DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10248998 ↗
• MalfunctionJul 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC STATED THAT THE RUBBER RING WAS MISSING AND RESERVOIR COMPARTMENT WAS CRACKED. CUSTOMER STATED THAT THEY WERE ABLE TO LOCK IN PLACE THE RESERVOIR WHEN INSERTED IN INSULIN PUMP. NO HARM WAS REQUIRED DURING MEDICAL INTERVENTION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10243334 ↗
• MalfunctionJul 5, 2020Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Power Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PRESS, LOST SETTING, LOW BATTERY WARNING, INSULIN PUMP TURNED 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 10231261 ↗
• InjuryJul 1, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 219 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INJECTIONS. CUSTOMER STATED THEY CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DID ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED RESERVOIR HAD AIR BUBBLES NOTICED DURING THERAPY. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10217232 ↗
• InjuryJul 1, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH FOOD. THE INSULIN PUMP WAS SHUTTING OFF. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10216460 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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-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