Paradigm® REAL-Time Revel™ MMT-523RNAB (UDI 00643169513051)Recalls & reported problems

Summary

The FDA's MAUDE database contains 376 adverse event reports that list this exact device (DI 00643169513051), received between May 11, 2017 and Jul 31, 2020 — classified as 3 deaths, 179 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (47 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 376 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 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 485 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED INSULIN FLOW BLOCK ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10348900 ↗
• MalfunctionJul 23, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A UNEXPECTED RESTART ERROR. CUSTOMER STATED THAT INSULIN PUMP HAD MULTIPLE ERROR ALARMS IN THE PUMP HISTORY. CUSTOMER STATED THAT THEY SUCCESSFULLY CLEARED THE ALARM. CUSTOMER STATED THAT THEY GOT UNEXPECTED RESTART ERROR AFTER 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 10313184 ↗
• MalfunctionJul 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. 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 10301399 ↗
• MalfunctionJul 20, 2020No Display/Image; Battery Problem; No Display/Image; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. CUSTOMER STATED THE BATTERY WAS CHANGED BUT THE ISSUE WAS NOT RESOLVED. CUSTOMER WAS ADVISED A BATTERY CAP WOULD BE SENT OUT. 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 10293981 ↗
• MalfunctionJul 10, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WERE 331 MG/DL, 273 MG/DL, 196 MG/DL, 233 MG/DL, 134 MG/DL, 205 MG/DL, 190 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10256873 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. CUSTOMER STATED THAT SHE WAS HOSPITALIZED WITH HEART PALPITATIONS, AND WHILE EXPERIENCED A HIGH BLOOD GLUCOSE OF 900 MG/DL. CUSTOMER ALSO MENTIONED OTHER BLOOD GLUCOSE VALUE OF 500 MG/DL. THE CUSTOMER WAS TREATED IN HOSPITAL FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTS THEY DID NOT CONTACT THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Complaint, Ill-Defined; Hyperglycemia

  MAUDE report 10250604 ↗
• InjuryJul 9, 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 FOR HIGH BLOOD GLUCOSE, HEART PALPITATION ON UNKNOWN DATE WITH BLOOD GLUCOSE LEVEL OF 900 MG/DL. CUSTOMER STATED OTHER BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Palpitations

  MAUDE report 10250581 ↗
• MalfunctionJul 9, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS GETTING RECURRING UNEXPECTED RESTART ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND COMPLETE THE REWIND PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10249399 ↗
• 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 WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND PALPITATIONS ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 900 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED INSULIN EXITED AT THE QUICK RELEASE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10243198 ↗
• InjuryJul 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HYPOGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 39 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD AND GLUCOSE TABLETS. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS SWEATING. THE CUSTOMER STATED THAT THEY ACCIDENTALLY DELIVERED TOO MUCH INSULIN AND NOW THEY HAD LOW BLOOD GLUCOSE. THE INSULIN PUMP WAS CHIPPED AT THE SIDE OF THE BATTERY. THE CUSTOMER HAD BEEN USING INSULIN, PUMP, SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Sweating

  MAUDE report 10222440 ↗
• MalfunctionJul 1, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WAS BLURRY AND SCRATCHED. CUSTOMER STATED THEY DID NOT READ THE MIDDLE OF THE SCREEN OF HER 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 10216702 ↗
• MalfunctionJun 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A INSULIN PUMP ERROR ALARM. THE CUSTOMER STATED THEY WERE NOT ABLE TO CLEAR 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 10183219 ↗
• MalfunctionJun 19, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART 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 10173203 ↗
• MalfunctionJun 18, 2020Date/Time-Related Software Problem; Date/Time-Related Software Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD ISSUE WITH TIME AND DATE. 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 10166504 ↗
• 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

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10132415 ↗
• MalfunctionJun 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND UNABLE TO REWIND THE INSULIN PUMP. CUSTOMER WAS UNSURE ABOUT DRIVE SUPPORT CAP WAS DAMAGED OR NOT. 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 10117904 ↗
• MalfunctionJun 4, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALARMED WITH TWO MOTOR ERRORS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 285 MG/DL AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117881 ↗
• MalfunctionJun 4, 2020Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Obstruction of Flow; Power Problem; Priming Problem; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Obstruction of Flow; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. INSULIN PUMP WAS SQUIRTING INSULIN DURING PRIME PROCESS. INSULIN PUMP HAD REJECTED NEW BATTERIES. INSULIN PUMP HAD LOCKED UP AND WAS UNRESPONSIVE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10117670 ↗
• MalfunctionMay 28, 2020Insufficient Flow or Under Infusion; Environmental Compatibility Problem; Insufficient Flow or Under Infusion; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ALLEGING THE OVER DELIVERY OF THE INSULIN. LAST NIGHT JUST BEFORE DINNER HIS BLOOD GLUCOSE WENT HIGH. THE CUSTOMER HAD GIVEN HIMSELF A SIGNIFICANT AMOUNT OF INSULIN AND HAD NOT EATEN TO COVER IT AND HID BLOOD GLUCOSE STARTED DROPPING SO HE DRANK 32 OZ OF COKE BEFORE IT STARTED GOING BACK UP. THE BLOOD GLUCOSE AT TIME OF INCIDENT WAS 112 MG/DL AND WAS TREATED WITH FOOD. THE DRIVE SUPPORT CAP APPEARS NORMAL. PERFORMED DISPLACEMENT TEST WHICH WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10095398 ↗
• MalfunctionMay 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACKED AND THE DISPLAY HAD DAMAGED. 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 10082582 ↗
• MalfunctionMay 20, 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 COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER STATED THAT INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. CUSTOMER STATED THAT 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 10073848 ↗
• MalfunctionMay 12, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM AFTER TROUBLESHOOTING. THE CUSTOMER RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER A 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 10048518 ↗
• MalfunctionMay 8, 2020No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ISSUES. THE CUSTOMER ALSO STATED THAT THE TIME WAS ADVANCING. THE CUSTOMER STATED THAT THE LIGHT DID NOT LIGHT UP SOMETIMES. 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 10038155 ↗
• MalfunctionMay 6, 2020Mechanical Problem; Insufficient Device Problem Information; Mechanical Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD TO REWIND MORE THAN ONCE. INSULIN PUMP WAS SLOWER DURING REWIND. 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 10028554 ↗
• MalfunctionMay 5, 2020Device Alarm System; Mechanical Problem; Obstruction of Flow; Connection Problem; Device Alarm System; Mechanical Problem; Obstruction of Flow; Connection Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR WAS LOOSE WHEN SCREWED IN. THERE WAS UNUSUAL NOISES DURING REWIND, THE INSULIN PUMP DID NOT GAVE ALERT WHEN RESERVOIR WAS LOW AND THERE WAS UNEXPLAINED NO INSULIN DELIVERY ALARMS. 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 10024118 ↗

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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-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-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-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