Paradigm® REAL-Time Revel™ MMT-723LNAH (UDI 00643169933149)Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00643169933149), received between Jan 4, 2018 and Apr 28, 2023 — classified as 52 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (23 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 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2023Material Integrity Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER STATED TO PUT THE BATTERY CAP BACK ON THE PUMP BUT IT WAS NOT FLUSH SO SHE TRIED TO TAKE IT OFF AND PUT IT BACK ON BUT THE CAP WILL NOT MOVE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER RESPONSE WAS CANNOT REMOVE THE BATTERY CAP AND STATES HAVING A LARGE, FLAT-HEAD SCREWDRIVER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER HAD DISCONTINUE TO USE THE DEVICE. THE PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829660 ↗
• MalfunctionSep 17, 2020Obstruction of Flow; Battery Problem; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM AND BATTERY LIFE WAS DIMINISHED. 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 10550241 ↗
• MalfunctionJul 15, 2020No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem; No Display/Image; Mechanical Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS. THE CUSTOMER STATED INSULIN PUMP DIED AND GOT WATER DAMAGE AND REWIND FUNCTION WAS NOT WORKING. 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 10274978 ↗
• 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 EXPERIENCE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10249283 ↗
• InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND 333 MG/DL. CUSTOMER WAS TREATED WITH BOLUS. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10216717 ↗
• MalfunctionJun 22, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THE USER EXPERIENCED A HIGH BLOOD GLUCOSE OF 240 MG/DL AND TREATED WITH INSULIN PUMP. THE USER ALLEGING THE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER REPORTED INSULIN PUMP SYSTEM HAD NOT BEEN IN USE WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10177930 ↗
• MalfunctionJun 17, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS UNABLE TO CLEAR ALARM. CUSTOMER STATED THAT THEY WERE NOT ABLE COMPLETE REWIND. DRIVE SUPPORT CAP WAS 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 10161910 ↗
• MalfunctionApr 29, 2020Device Alarm System; Device Alarm System

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE LOW RESERVOIR WARNING WAS HARD TO HEAR. 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 10012324 ↗
• MalfunctionApr 16, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR, BUTTONS WERE STICKY AND NO DELIVERY. CUSTOMER SAID BLOOD GLUCOSE AT THE TIME OF INCIDENT UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9966467 ↗
• MalfunctionApr 9, 2020Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Device Alarm System; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTON OF THE INSULIN PUMP WAS HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP MADE GRINDING NOISE. CUSTOMER REPORTED NO DELIVERY ALARMS. 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 9942928 ↗
• InjuryApr 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF OVER 400 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND A BEND IN THE SET CANNULA. THE CUSTOMER STATED INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9909985 ↗
• MalfunctionApr 1, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PROVIDED. NO ALARMS WERE CLEARED. INSULIN DID NOT EXIT THE TUBING WITH MANUAL PRIME. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909946 ↗
• InjuryMar 31, 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 ON UNKNOWN DATE DUE TO LOW BLOOD GLUCOSE LEVEL OF 35 MG/DL. THE CUSTOMER DID NOT REPORT SYMPTOMS OR TREATMENT RELATED TO LOW BLOOD GLUCOSE LEVEL. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9905256 ↗
• InjuryMar 19, 2020Mechanical Problem; Detachment of Device or Device Component; Power Problem; No Apparent Adverse Event; Mechanical Problem; Detachment of Device or Device Component; Power Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE LEVEL OF 30 MG/DL. CUSTOMER STATED THE INSULIN PUMP WAS NOT WORKING. CUSTOMER REPORTED THEY WERE UNSURE IF THE DRIVE SUPPORT CAP WAS PROTRUDED, LOOSE, STICKING OUT OR FLUSH. CUSTOMER STATED THAT INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWOUND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9852551 ↗
• InjuryMar 16, 2020Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Communication or Transmission 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 504 MG/DL AND THEY DID NOT ABLE TO BOLUS, DUE TO WHICH THEIR BLOOD GLUCOSE WAS HIGH. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM, PERFORMED A 5.0 UNIT FIXED PRIME AND INSULIN EXITED. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9834134 ↗
• InjuryFeb 13, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HOSPITALIZED DUE TO HYPERGLYCEMIA. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER REPORTED THAT SHE STOPPED USING THE INSULIN PUMP A LONG TIME AGO WHEN SHE WAS HOSPITALIZED AND EVER SINCE SHE WAS NOT ABLE TO USE IT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER REPORTED THAT THE INSULIN PUMP NOT SHOWS SIGNS OF PHYSICAL DAMAGE, NOT DROPPED OR BUMPED .CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9705157 ↗
• MalfunctionFeb 10, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER REPORTED INSULIN PUMP DID REQUIRE REWIND. CUSTOMER ABLE TO COMPLETE REWIND. AFTER TROUBLESHOOTING THE ALARM WAS RECURRING. 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 9685857 ↗
• MalfunctionFeb 4, 2020Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCRATCHES ON SCREEN THAT SOMETIMES MAKE THE SCREEN HARDER TO READ. THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS. 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 9663263 ↗
• MalfunctionJan 7, 2020Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PART ON THE BOTTOM OF INSULIN PUMP, NEXT TO WHERE THE CLIP WRAPS UNDER, THAT WAS BROKEN OFF AND EXPOSING THE SILVER UNDERSIDE OF THE RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9556737 ↗
• MalfunctionJan 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD RECEIVED UNEXPECTED RESTART. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 180 MG/DL. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARMS AND WERE ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER STATED THAT INSULIN PUMP ERROR RECURRED AFTER INSERTING THE NEW BATTERY. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552807 ↗
• MalfunctionDec 25, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 171 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9517901 ↗
• InjuryDec 11, 2019Adverse 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 LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS ALMOST 500 MG/DL AND 400 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP AND PEN. CUSTOMER STATED INFUSION SET TUBING WAS DETACHED. CUSTOMER DID NOT WANT TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 9449660 ↗
• MalfunctionDec 6, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTS THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTED THAT THE AFTER CHANGING THE BATTERY RECEIVED ANOTHER ALARM. THE CUSTOMER WAS ADVISED TO CONTINUE TO WEAR THE INSULIN PUMP UNTIL REPLACEMENT ARRIVES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9422465 ↗
• MalfunctionDec 5, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 303 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL OR SLIGHTLY INDENTED. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NEITHER DROPPED NOR BUMPED. THE CUSTOMER WAS ABLE TO COMPLETE THE INSULIN PUMP REWIND. 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: Hyperglycemia

  MAUDE report 9421177 ↗
• MalfunctionDec 5, 2019No Display/Image; No Display/Image

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND CUSTOMER REPORTS DISPLAY WAS BLANK CURRENTLY. CUSTOMER STATES THE DISPLAY WAS NOT BLANK LESS THAN 30 SECONDS AND DID NOT RETURN. THE CUSTOMER REMOVES THE BATTERY AND STATED THE INSERT BATTERY ALARM DID NOT DISPLAY ON THE INSULIN PUMP SCREEN. CUSTOMER STATES THE CONTACT ON THE BATTERY CAP WAS NEITHER MISSING NOR DAMAGE. CUSTOMER STATES BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9416417 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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