Paradigm® REAL-Time Revel™ MMT-723RNAH (UDI 00643169513112)Recalls & reported problems

Summary

The FDA's MAUDE database contains 512 adverse event reports that list this exact device (DI 00643169513112), received between Jun 1, 2017 and Jul 11, 2023 — classified as 3 deaths, 260 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (64 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 512 reports, in the reporter's own words as published by the FDA.

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

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PUMP ALARMED THAT IS THE INSULIN FLOW BLOCKED OR NO DELIVERY AND ALSO RECEIVED MOTOR ERROR. THE CUSTOMER ALSO EXPERIENCED HYPERGLYCEMIA BUT THE BLOOD GLUCOSE VALUE AT THE TIME OF THE CALL WAS UNKNOWN. NOFURTHER COMPLICATIONS WERE REPORTED . TROUBLESHOOTING WAS PERFORMED . IT WAS UNKNOWN WHETHER THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF THE REPORTED EVENT AND UNKNOWN WHETHER THE AUTO MODE FEATURE WAS TURNED ON DURING THE REPORTED EVENT. IT WAS UNKNOWN WHETHER THE CUSTOMER WILL CONTINUE TO USE THE INSULIN PUMP. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 17295720 ↗
• MalfunctionSep 21, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND 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 10559461 ↗
• MalfunctionAug 31, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL-SLIGHTLY INDENTED. THE CUSTOMER STATED THAT THE RETAINER RING WAS CRACKED BUT RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 10471027 ↗
• MalfunctionAug 5, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Priming Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD 2-3 ERROR CODES AND BUTTON ERROR ALARM. CUSTOMER STATED INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS. CUSTOMER STATED INSULIN PUMP LOST TIME OF DAY SETTINGS AND SQUIRTED INSULIN WHEN PRIMING. 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 10366888 ↗
• MalfunctionAug 3, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE AND STOPPED WORKING. 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 10355897 ↗
• InjuryAug 3, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD TWO MOTOR ERROR ALARMS. THE CUSTOMER'S BOYFRIEND WAS ON THE PHONE AS THE PARAMEDICS WERE ALSO THERE. CUSTOMER STATED THEY DID NOT FELL WELL ENOUGH TO TROUBLESHOOT. CUSTOMER HAD THE SYMPTOMS LIKE VOMITING. CUSTOMER¿S BLOOD GLUCOSE WAS 253 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Vomiting

  MAUDE report 10354717 ↗
• InjuryAug 1, 2020Device Alarm System; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Alarm System; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL WHICH WAS TREATED WITH THE INSULIN PUMP. THE INSULIN PUMP HAD A CRACK ON THE BOTTOM OF THE SCREEN. THE CUSTOMER STATED THAT OVER TIME THE ACTIVATION AND ESCAPE BUTTONS HAD GOTTEN HARD TO PUSH AND THE INSULIN PUMP WAS NOT RECEIVING LOW BATTERY ALERTS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10353959 ↗
• InjuryJul 31, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON UNKNOWN DATE WITH BLOOD GLUCOSE OF UNKNOWN. CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERRORS. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA AND VOMITING. CUSTOMER WAS ABLE TO CLEAR ALARM AND INSULIN PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348718 ↗
• MalfunctionJul 30, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED DRIVE SUPPORT CAP APPEARS NORMAL. TROUBLESHOOTING WAS PERFORMED. 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 10343964 ↗
• MalfunctionJul 29, 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 STATED THAT THE DISPLAY DID NOT RETURNED. 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 10337284 ↗
• InjuryJul 28, 2020Device Alarm System; No Apparent Adverse Event; Device Alarm System; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 576 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH 6 UNITS OF INSULIN. CUSTOMER REPORTED THAT NO INSULIN CAME OUT FROM TUBING, NO ALARMS WERE RECEIVED. CUSTOMER DECLINED FURTHER TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10331845 ↗
• InjuryJul 28, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 587 MG/DL. CUSTOMER WAS NOT USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER TREATED WITH INSULIN DRIP IN THE HOSPITAL. CUSTOMER STATED THEY TREATED IN INTENSIVE CARE UNIT. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, THIRSTY AND MIGRAINE. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea; Polydipsia

  MAUDE report 10331191 ↗
• MalfunctionJul 28, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10330959 ↗
• MalfunctionJul 24, 2020Obstruction of Flow; Patient Device Interaction Problem; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE SCREEN WAS CHIPPED AND INSULIN PUMP HAD A NO DELIVERY ALARMS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10318725 ↗
• MalfunctionJul 23, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM DURING SET CHANGE. NO FURTHER DETAILS GIVEN. 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 10313822 ↗
• MalfunctionJul 22, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM 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 10312058 ↗
• MalfunctionJul 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 AND ACT BUTTON WAS NOT WORKING. TROUBLESHOOTING WAS DONE FOR KEYPAD ANOMALY. CUSTOMER REPORTED THAT THE TIME WAS NOT ADVANCING ON 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 10306777 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE MOTOR ERRORS AND THE RESERVOIR WAS CHIPPED. THE CUSTOMER REPORTED THAT THE ACTIVATION BUTTON WAS HARD TO PRESS BUT THEN IT STARTED WORKING AGAIN. THE INSULIN PUMP HAD A LOW BATTERY ALARM. THE CUSTOMER STATED THAT THE INSULIN HAD RAINBOW EFFECT ON THE DISPLAY SOMETIMES ONLY WHEN THEY WENT OUTSIDE. 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 10306671 ↗
• MalfunctionJul 21, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. IT WAS STATED THE INSULIN PUMP REJECTED BATTERY, THERE WAS CHIPPING IN THE RESERVOIR WHEN THE CUSTOMER UNSCREWS IT, RAINBOW EFFECT ON INSULIN PUMP SCREEN WHEN IN BRIGHT LIGHT, ACT BUTTON WAS HARDER TO PRESS AND USE ON OCCASIONS, UNEXPLAINED NON 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 10300621 ↗
• MalfunctionJul 17, 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. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. 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 10287516 ↗
• MalfunctionJul 16, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A COMPROMISED FORCED SENSOR SYSTEM ERROR ALARM AFTER REWINDING AND PRIMING. 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 10281901 ↗
• InjuryJul 9, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 420 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVEL OF 360 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WENT BLANK AND STOPPED WORKING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10249347 ↗
• MalfunctionJun 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP DID NOT WORK. THE CUSTOMER WAS LOOKING FOR WARRANTY INFORMATION. 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 10205121 ↗
• 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 INSULIN PUMP HAD MOTOR ERROR AND ACT BUTTON WAS HARDER TO GET RESPONSE. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER PERFORMED DISPLACEMENT TEST AND IT WAS PASS. 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 10194216 ↗
• MalfunctionJun 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR RING WAS CRACKED. CUSTOMER STATED THAT THE RESERVOIR DID LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER STATED THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THE INFUSION SET AND RESERVOIR DID NOT SHOW SIGNS OF DAMAGE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10187998 ↗

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-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• Z-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• 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-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-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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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