Paradigm® REAL-Time Revel™ MMT-523RNAP (UDI 00643169513082)Recalls & reported problems

Summary

The FDA's MAUDE database contains 362 adverse event reports that list this exact device (DI 00643169513082), received between Jun 3, 2017 and Sep 4, 2020 — classified as 174 injuries, 188 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (54 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 362 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING WAS BROKEN HOWEVER THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE 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 10493587 ↗
• MalfunctionAug 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT TOP OF THE 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 10425007 ↗
• InjuryAug 6, 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'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS 600 MG/DL. CUSTOMER OTHER BLOOD GLUCOSE WAS 522 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THE SITE FILLS ITCHY, SITE FROM LAST NIGHT. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION AS WELL BOLUS FOR HIGH BLOOD GLUCOSE. CUSTOMER ATE SOME PIZZA LAST NIGHT, SHE BLOUSED, BLOOD GLUCOSE DID NOT GO BACK DOWN. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THEY DID ALLEGING INSULIN PUMP FOR UNDER DELIVERY BECAUSE SHE BOLUSES AND KEEPS GOING HIGH. CUSTOMER STATED THAT THEY DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED INSULIN EXITED AT THE QUICK RELEASE. CUSTOMER STATES THE CANNULA WAS NOT BENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Itching Sensation

  MAUDE report 10372559 ↗
• MalfunctionJul 31, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. CUSTOMER STATED THEY HEARING UNUSUAL NOISES DIFFERENT FROM NORMAL GRINDING NOISES. 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 10348633 ↗
• MalfunctionJul 29, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Insufficient Device Problem Information; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NOT EASY TO PUSH. THE CUSTOMER STATED INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS, UNEXPLAINED RANDOM ERROR MESSAGES AND DIMMER BACKLIGHT. 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 10336677 ↗
• InjuryJul 20, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE RECEIVED EMERGENCY MEDICAL SERVICES FOR HIGH BLOOD GLUCOSE ON (B)(6) 2020. BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER ALLEGING THAT INSULIN PUMP WAS NOT DELIVERING INSULIN. THE CUSTOMER¿S LAST BLOOD GLUCOSE READING WAS AROUND 280 MG/DL TO 290 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10295523 ↗
• InjuryJul 20, 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 WAS IN EMERGENCY ROOM DUE TO HYPERGLYCEMIA ON (B)(6) 2020. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF HOSPITALIZED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10294480 ↗
• MalfunctionJul 15, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP FAILED TO DELIVERED INSULIN AND DID NOT GET NEW 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 10275779 ↗
• MalfunctionJul 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ERROR. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THEY REPLACE THE BATTERY AND GOT ERROR AGAIN. 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 10232483 ↗
• MalfunctionJun 30, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR DID LOCK IN PLACE INTO THE INSULIN PUMP. THE CUSTOMER ALSO STATED THAT THE RESERVOIR CASE AREA WAS CRACKED. 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 10211162 ↗
• MalfunctionJun 25, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE NOT RESPONDING AND UNABLE TO REWIND. THE CUSTOMER STATED THAT MOST OF THE BUTTONS WERE UNRESPONSIVE. 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 10193316 ↗
• MalfunctionJun 16, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT BUTTON OF INSULIN PUMP DID NOT WORK. THE CUSTOMER NOTICED SURFACE ON ARROWS HAD STARTED TO 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 10156461 ↗
• MalfunctionJun 2, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND 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 10107985 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 455 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER DID BOLUS STILL CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD BLOOD GLUCOSE LEVELS OF 140, 301, 331, 317,362, 319, 315, 180, 179, 205 AND 291 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DECLINED TO CHECK AIR BUBBLES AND LEAK. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE LEVEL EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-UNK, UNOMED SET.

  Patient problems: Hyperglycemia

  MAUDE report 10095149 ↗
• MalfunctionMay 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PLASTIC ON THE TOP OF RESERVOIR COMPARTMENT WAS MISSING. THE CUSTOMER STATED THAT THE RESERVOIR WAS LOCK IN PLACE. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. 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 10041776 ↗
• MalfunctionMay 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF THE INSULIN PUMP WERE UNRESPONSIVE. 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 10027752 ↗
• MalfunctionApr 30, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE THERE IS DAMAGE TO THE PUMP AND THE PLASTIC WAS CHIPPING AWAY FROM THE TOP OF THE RESERVOIR AND BATTERY COMPARTMENT. RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE 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 10013443 ↗
• InjuryApr 28, 2020Battery Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS, DIABETIC KETOACIDOSIS AND HOSPITALIZATION. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE VIA IV FLUID AND MEDICAL DAILY INSULIN. CUSTOMER ADVISED THE INSULIN PUMP WAS TAKEN OFF OF THE PATIENT BY THE HOSPITAL AND THE BATTERY DIED WHICH RESULTED IN THE INSULIN PUMP BEING OFF. CUSTOMER WAS ADVISED TO CHANGE OUT THEIR ENTIRE INFUSION SET, RESERVOIR, INSULIN AND TREAT THEIR BLOOD GLUCOSE VIA HEALTHCARE PROVIDER'S INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10006309 ↗
• MalfunctionApr 20, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 9979936 ↗
• InjuryApr 16, 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. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 487 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE LEVEL WAS 461 MG/DL. CUSTOMER STATED THAT SHE CHANGE THE SITE AND GAVE HERSELF 4 UNIT OF INSULIN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH BOLUS FOR HIGH BLOOD GLUCOSE. CUSTOMER WAS 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 RAN THE 5U FIX PRIME TEST AND THE INSULIN CAME OUT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9967075 ↗
• MalfunctionApr 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR COMPARTMENT WAS BROKEN. CUSTOMER REPORTED THAT THERE WAS PHYSICAL DAMAGE TO THE INSULIN PUMP'S RESERVOIR LIP RING AND THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957281 ↗
• MalfunctionApr 13, 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 ERROR, THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS AND ALSO THE DRIVE SUPPORT CAP WAS PROTRUDED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9954642 ↗
• MalfunctionApr 9, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THE SPRING WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER ALSO STATED THAT THE DISPLAY DID NOT RETURNED AFTER PUMP RESTART. 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 9942886 ↗
• MalfunctionApr 9, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NON RESPONSIVE AND UNSPECIFIED INSULIN PUMP ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. CUSTOMER STATED THAT THE SOMETIMES REWINDING WAS LOUDER. 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 9942748 ↗
• MalfunctionApr 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ISSUE. THE CUSTOMER STATED THAT THE DOWN ARROW KEY WAS NOT WORKING. THE CUSTOMER ALSO STATED THAT 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 9927884 ↗

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-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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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