Paradigm® REAL-Time Revel™ MMT-523RNAP (UDI 00643169221543)Recalls & reported problems

Summary

The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00643169221543), received between Jun 5, 2017 and Aug 12, 2020 — classified as 1 death, 44 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (12 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 93 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2020Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; 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 WAS REPORTED THAT INSULIN PUMP HAD BUTTON ERROR ALARM, THE ALARM WAS NOT CLEARED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10396038 ↗
• MalfunctionAug 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP AND DOWN ARROW BUTTONS WERE STICKING AND HAD TO PRESS TWICE FOR EVERY SINGLE 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 10373340 ↗
• MalfunctionApr 22, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT TIME WAS ADVANCE. 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 9985287 ↗
• MalfunctionFeb 27, 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 INSULIN PUMP BUTTON WAS STUCK. CUSTOMER STATED THAT INSULIN PUMP HAD NO DELIVERY ALARM AND REJECT 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 9760776 ↗
• DeathSep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY AT HOME ON (B)(6) 2018 DUE TO DIABETES AND KIDNEY PROBLEMS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH, BUT CALLER REPORTED THAT IT HAD GONE DOWN AS LOW AS 25 MG/DL IN THE PAST, BUT WAS NOT SURE OF THE READINGS AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH, BUT IT WAS REMOVED THAT DAY. THE CUSTOMER WAS NOT USING SENSORS. CALLER DECLINED UPLOADING PUMP INTO CARELINK. CALLER AGREED TO RETURN PRODUCTS AND IT¿S EXPECTED TO RETURN FOR FAILURE ANALYSIS.

  Patient problems: Death

  MAUDE report 9132725 ↗
• MalfunctionSep 9, 2019Mechanical Problem; Battery Problem; Priming Problem; Mechanical Problem; Battery Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN SQUIRTING DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP WAS LOUDER DURING REWIND, HANGING BATTERY EVERY 10-14 DAYS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8974280 ↗
• MalfunctionAug 12, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP'S BUTTONS STICK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD REJECTED BATTERIES, AND THERE WERE RANDOM NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882307 ↗
• MalfunctionAug 8, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR, CHANGED SITE AND STARTED OVER. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8872855 ↗
• MalfunctionAug 8, 2019Device Alarm System; Display or Visual Feedback Problem; Device Alarm System; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP'S ALARMS WERE SOFT, SHE COULD HARDLY HEAR AND THE SCREEN WAS DIMMER. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN 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 8872751 ↗
• MalfunctionAug 6, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON UNRESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 148 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862964 ↗
• MalfunctionJun 27, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS QUIRTS OUT INSULIN DURING PRIMING AND SLOWER IN REWIND AS WELL AS HAS TO PRESS BUTTONS 2 OR 3 TIMES TO WORK. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REJECTED NEW BATTERY AND RECEIVED UNEXPLAINED NO DELIVERY ALARMS, ALSO INSULIN PUMP DIDN'T UPDATE DATE OF CHANGING OUT INFUSION SET CORRECTLY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738434 ↗
• InjuryMay 27, 2019Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; 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) 2019. THE CUSTOMER'S BLOOD GLUCOSE WAS 573 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE CUSTOMER STATED THEY GAVE BOLUS TO THEMSELVES BUT BLOOD GLUCOSE WAS NOT GOING DOWN. BASED ON CUSTOMER REPORT CUSTOMER DID ALLEGE PUMP WAS UNDER DELIVERING. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER DID NOT REPORT AIR BUBBLES AND LEAK IN BOTH RESERVOIR AND TUBING. CUSTOMER WAS UNABLE TO COMPLETE CARELINK UPLOAD. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8643633 ↗
• InjuryMay 24, 2019Adverse 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 400 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8639499 ↗
• MalfunctionMay 8, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD BUTTON ERROR AND BUTTONS WERE NOT RESPONDING. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8589878 ↗
• MalfunctionApr 26, 2019Adverse 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 LEVEL 42 MG/DL. THE CUSTOMER WAS TREATED WITH CARBS. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS FOR LOW BLOOD GLUCOSE LEVEL. TROUBLESHOOTING WAS NOT PERFORMED FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8553681 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 476 MG/DL. THE CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 450 MG/DL, 451 MG/DL, 340 MG/DL AND 136 MG/DL. THE CUSTOMER WAS TREATED WITH SHOT. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING SYMPTOMS OF THEIR HIGH BLOOD GLUCOSE EPISODES. TROUBLESHOOTING WAS DECLINED BY THE CUSTOMER FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8547979 ↗
• InjuryApr 19, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Premature Discharge of Battery; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 51 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD A PUMP ERROR ALARM. THE CUSTOMER STATED THAT THE BUTTONS WERE NOT RESPONDING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8530671 ↗
• MalfunctionMar 26, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR TUBE LIP OF THE INSULIN PUMP WAS CRACKED. THE CUSTOMER DID NOT PROVIDE THEIR BLOOD GLUCOSE VALUE AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT PROVIDE INFORMATION ON EVENTS LEADING UP TO THE INCIDENT. TROUBLESHOOTING WAS PERFORMED AND DID NOT RESOLVE THE ISSUE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8451433 ↗
• MalfunctionMar 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 159 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8442928 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER'S BLOOD GLUCOSE WAS 44 MG/DL AT ONE POINT BEFORE MAKING CALL TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8442622 ↗
• MalfunctionMar 14, 2019Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND THERE WERE FEW SCRATCHES ON THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPOT THAT THE INSULIN PUMP HAD RAINBOW EFFECT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8419660 ↗
• InjuryFeb 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. THE CUSTOMER TREATED WITH THE MANUAL INJECTION. THE CUSTOMER REPORTED THAT THEY HAD RECEIVED THE NO DELIVERY ALARM. TROUBLESHOOTING WAS DECLINED FOR HIGH BLOOD GLUCOSE AND PERFORMED FOR NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN EXITED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8377105 ↗
• MalfunctionFeb 18, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED SHUT OFF AND CANNOT DO ANYTHING WITH IT. THE CUSTOMER¿S BLOOD GLUCOSE WAS 120 MG/DL. CUSTOMER TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8348830 ↗
• MalfunctionFeb 14, 2019Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT ALERTING WHEN BATTERY WAS LOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN 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 8338839 ↗
• MalfunctionFeb 12, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 105MG/DL. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE REWIND. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330617 ↗

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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-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