Paradigm® REAL-Time Revel™ MMT-523NAL (UDI 00643169693746)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169693746), received between Jun 5, 2018 and Jul 11, 2023 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (3 reports).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2023Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED THAT NO DELIVERY ALARM FOR THE PUMP. TROUBLESHOOTING WAS PERFORMED AND THE ISSUE WAS RESOLVED BY CHANGING THE COMPLETE SET. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE DEVICE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17295703 ↗
• MalfunctionJul 6, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE HALF DRIVE SUPPORT CAP WAS INTENDED AND HALF WAS STICKING. 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 10231303 ↗
• MalfunctionAug 19, 2019Obstruction of Flow; Battery Problem; Power Problem; Obstruction of Flow; Battery Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP SHUT OFF WITHOUT WARNING LOW LIFE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT BATTERY LIFE DID NOT LAST FULL SEVEN DAYS, INSULIN PUMP REJECTED NEW BATTERY, FAILED BATTERY TEST AND UNEXPLAINED NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8904853 ↗
• MalfunctionJul 15, 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 INSULIN SQUIRTING DURING PRIMING RATHER THAN A SLOW DRIP AND BUTTONS WERE LESS RESPONSIVE AND ACT BUTTON WAS HARD TO PRESS TWICE. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT INSULIN PUMP REJECTED NEW BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8787952 ↗
• MalfunctionJul 1, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SEVERAL ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED CHIP OFF INSULIN PUMP RESERVOIR TUBE LIP AND THE BUTTONS WERE HARD TO PUSH. CUSTOMER DECLINED TROUBLESHOOTING. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747584 ↗
• MalfunctionApr 11, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 107 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE BUTTON OF THE INSULIN PUMP WAS NOT RESPONDING. ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502694 ↗
• MalfunctionApr 10, 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 THE INSULIN PUMP HAD LOW BLOOD GLUCOSE. THE CUSTOMER¿S LOW BLOOD GLUCOSE WAS 51 MG/DL AND THE CURRENT BLOOD GLUCOSE WAS 385 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER DECLINED TROUBLESHOOTING FOR THE LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8498482 ↗
• MalfunctionFeb 15, 2019Physical Resistance/Sticking

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PUSH. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344443 ↗
• MalfunctionJan 11, 2019Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN OFF NO POWER ALARM WITHOUT A LOW BATTERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 115 MG/DL. THE CUSTOMER REPORTED THAT THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. THE CUSTOMER REPORTED THAT THIS WAS NOT THE SECOND OCCURRENCE OF OFF NO POWER IN LESS THAN 24 HOURS AFTER LOW BATTERY WARNING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8238760 ↗
• MalfunctionOct 26, 2018Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN DOES NOT SHOW IMAGES OR TEXT. THE CUSTOMERS BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERIES AND SHOWS UNEXPLAINED NO DELIVERY ALARM. THE INSULIN PUMP HAS TO RESET PUMP SETTINGS RANDOMLY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8008245 ↗
• MalfunctionJul 18, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS ABOVE 600 MG/DL. THE CUSTOMER WAS UNCOMFORTABLE WITH THE INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 7700253 ↗
• InjuryJul 11, 2018Adverse 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 DUE TO HIGH BLOOD GLUCOSE ON (B)(6) WITH BLOOD GLUCOSE OF ABOVE 600MG/DL. THE CUSTOMER'S EXPERIENCED DIFFERENT BLOOD GLUCOSE LEVEL WAS 181, 340, 260, 295, 580 MG/DL. THE CUSTOMER WAS TREATED WITH 3 UNITS, IV FLUIDS. TROUBLESHOOTING WAS DONE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 7680333 ↗
• InjuryJun 5, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE BLOOD GLUCOSE OF 457 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 319 MG/DL. PATIENT'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 515 MG/DL. THE CUSTOMER DID EXPERIENCED THE SYMPTOMS SUCH AS VOMITING. THE CUSTOMER TREATED WITH THE BOLUS. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. 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 DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7568607 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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