Paradigm® REAL-Time Revel™ MMT-523NAL (UDI 00643169507180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 671 adverse event reports that list this exact device (DI 00643169507180), received between May 16, 2017 and Jan 3, 2024 — classified as 1 death, 201 injuries, 469 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (142 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 671 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2024Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 598 MG/DL AT THE TIME OF THE EVENT. THE HYPERGLYCEMIA WAS TREATED WITH THE INSULIN PUMP. ALSO REPORTED THAT THE PUMP RECEIVED NO DELIVERY ALARM DURING MANUAL PRIMING AND BLOOD AT THE SITE ON THE SENSOR. TROUBLESHOOTING WAS DECLINED FOR HYPERGLYCEMIA. IT WAS UNKNOWN WHETHER THE CUSTOMER HAD USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED HIGH BLOOD GLUCOSE EVENT OR WHETHER THE CUSTOMER USED THE SMARTGUARD AUTO MODE OF THE INSULIN PUMP OR NOT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE DEVICE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hyperglycemia

  MAUDE report 18433477 ↗
• MalfunctionMay 19, 2021Loss of Data; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND WAS ABLE TO COMPLETE REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846528 ↗
• MalfunctionOct 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT PIECE OF RESERVOIR COMPARTMENT WAS MISSING. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10668306 ↗
• MalfunctionSep 16, 2020No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WENT BLANK, THEY WERE ABLE TO GET IT BACK AND RECEIVED BATTERY OUT LIMIT AND BOLUS STOPPED ALARM. THEY WERE ABLE 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 10539392 ↗
• MalfunctionSep 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CHEWED UP. 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 10521828 ↗
• MalfunctionAug 6, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WONT REWIND ALL THE WAY DOWN. 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 10371933 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Insufficient Flow or Under Infusion; Mechanical Problem; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THE USER ALLEGED THAT THEY DID NOT BE GETTING THE PROPER AMOUNT OF INSULIN DUE TO A PROBLEM WITH THE INSULIN PUMP'S PISTON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10366111 ↗
• MalfunctionAug 4, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS STOPPED WORKING AND SCREEN OF INSULIN PUMP WAS BLANK. CUSTOMER STATED THAT BATTERY COMPARTMENT WAS CRACK. 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 10360556 ↗
• MalfunctionAug 3, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT BATTERY COMPARTMENT AND RESERVOIR LIP RING WAS CHIPPED. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10354464 ↗
• MalfunctionJul 28, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR 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 10330980 ↗
• InjuryJul 23, 2020Excess Flow or Over-Infusion; Mechanical Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Excess Flow or Over-Infusion; Mechanical Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A LOW BLOOD GLUCOSE VALUE OF 44 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS 34 MG/DL AND 89 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS TREATED WITH FOOD AND GLUCOSE TABLET. BASED ON CUSTOMER REPORTED CUSTOMER BELIEVED INSULIN PUMP WAS OVER-DELIVERING. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND BUTTON DID NOT WORK. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10313530 ↗
• MalfunctionJul 22, 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 COMPROMISED FORCE SENSOR SYSTEM ALARM WHILE FILLING THE RESERVOIR. CUSTOMER STATED DRIVE SUPPORT CAP WAS NOT 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 10306912 ↗
• InjuryJul 22, 2020Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL DUE TO THE MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 400 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. THE INSULIN PUMP HAD SMALL CRACKS NEAR RESERVOIR PORT. THE INSULIN PUMP RECEIVED RANDOM AND UNEXPLAINED NO DELIVERY ALERTS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10306721 ↗
• MalfunctionJul 21, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DOWN BUTTON WAS STICK DOWN. CUSTOMER STATED THAT INSULIN PUMP RECEIVED FAILED BATTERY AND IT RECEIVED 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 10301099 ↗
• MalfunctionJul 21, 2020Premature Discharge of Battery; No Display/Image; Moisture or Humidity Problem; Patient Device Interaction Problem; Premature Discharge of Battery; No Display/Image; Moisture or Humidity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. INSULIN PUMP HAD CRACK AND WAS EXPOSED TO MOISTURE. INSULIN PUMP DIDN'T TURN ON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300536 ↗
• MalfunctionJul 20, 2020Premature Discharge of Battery; No Display/Image; Premature Discharge of Battery; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING AFTER PUTTING NEW BATTERY. INSULIN PUMP HAD A PUMP ERROR ALARM AFTER IT GOT WET IN RAIN. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER STATED THAT INSULIN PUMP WAS SHUTDOWN AGAIN. 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 10294193 ↗
• InjuryJul 17, 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 475 MG/DL. CUSTOMER STATED THAT CANNULA OF INFUSION SET WAS BENT. CUSTOMER WAS DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10287831 ↗
• InjuryJul 16, 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 HAD HIGH BLOOD GLUCOSE LEVEL OF 498 MG/DL. CUSTOMER STATED THAT THE CANNULA WAS BENT. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10287324 ↗
• MalfunctionJul 16, 2020Device Alarm System; Battery Problem; Device Alarm System; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY NOT BEING ABLE TO HEAR SOME ALERTS. CUSTOMER STATED THAT BATTERIES NOT LASTING FULL 7 DAYS. 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 10281778 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS LOUDER DURING REWIND, ACT BUTTON WAS HARD TO PRESS, SCREEN WAS SCRATCHED AND THE BOTTOM OF THE PLATE WAS MISSING FROM BOTTOM OF INSULIN PUMP CASE. 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 10275731 ↗
• InjuryJul 7, 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 LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 548 MG/DL AT THE TIME OF THE INCIDENT AND OTHER VALUE WAS 586 MG/DL. CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10237904 ↗
• MalfunctionJul 6, 2020Failure to Cycle; Mechanical Problem; Visual Prompts will not Clear; Battery Problem; Failure to Cycle; Mechanical Problem; Visual Prompts will not Clear; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME AND INSULIN PUMP WAS FROZEN. THE CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM, BATTERY LESS THAN A WEEK AND GRINDING NOISE 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 10237852 ↗
• MalfunctionJul 1, 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 INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE. CUSTOMER REPORTED THAT THEY GOT RANDOM NO DELIVERY ALARMS. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD POOR BATTERY LIFE. 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 10217564 ↗
• MalfunctionJun 29, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CRACK LEFT SIDE OF SCREEN AND BUTTON WERE LESS RESPONSIVE. CUSTOMER STATED THAT THEY CHANGED BATTERY FREQUENTLY AND REWIND PROCESS WAS SLOWER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205241 ↗
• MalfunctionJun 25, 2020Device Alarm System; Failure to Cycle; Device Alarm System; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR ALARM DETECTED. CUSTOMER STATED THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. CUSTOMER STATED THEY WERE STUCK IN REWIND AND ALSO 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 10194323 ↗

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