Paradigm® REAL-Time Revel™ MMT-723LNAL (UDI 00643169933156)Recalls & reported problems

Summary

The FDA's MAUDE database contains 441 adverse event reports that list this exact device (DI 00643169933156), received between Jan 3, 2018 and Aug 4, 2020 — classified as 4 deaths, 184 injuries, 253 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (100 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 441 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2020Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN HAD HAZINESS WHICH MADE IT HARD TO READ, SCREEN WAS DIMMING, THERE WAS HAIRLINE CRACK ON THE RESERVOIR COMPARTMENT AND THE CORNER OF DEVICE AND PRIMING TOOK LONGER TO PROCESS. 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 10362171 ↗
• InjuryJul 31, 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. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 570 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE VALUE WAS 562 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER REPORTED THAT THE CANNULA WAS BENT. CUSTOMER TREATED WITH INSULIN PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10348923 ↗
• MalfunctionJul 15, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD TO PRESS BUTTONS MORE THAN ONCE TO GET INSULIN PUMP TO RESPOND, NO 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 10275952 ↗
• MalfunctionJul 13, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTONS ARE NOT RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264214 ↗
• MalfunctionJul 13, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND MULTIPLE NO DELIVERY ALARMS. THE DRIVE SUPPORT CAP WAS NORMAL-SLIGHTLY INDENTED. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE CUSTOMER PERFORMED DISPLACEMENT TEST AND TEST WAS SUCCESSFUL AND MOTOR ALARM DID NOT RECUR. 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 10262953 ↗
• InjuryJul 1, 2020Mechanical Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Mechanical Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WENT UP TO 500 MG/DL. CUSTOMER WAS TREATED WITH INSULIN. CUSTOMER REPORTED THAT INSULIN PUMP HAD MOTOR ERROR ALARM DURING REWIND. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR ALARM AND ABLE TO COMPLETE REWIND PROCESS. CUSTOMER STATED THAT INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10217136 ↗
• InjuryJun 30, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. CUSTOMERS STATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10210485 ↗
• InjuryJun 29, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 567 MG/DL AND 500 MG/DL. CUSTOMER TREATED WITH PEN. CUSTOMER DECLINED TROUBLESHOOTING. CUSTOMER STATED INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10206408 ↗
• MalfunctionJun 26, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT DOWN ARROW BUTTON WAS NOT WORKING. THE CUSTOMER OBSERVED TIME CLOCK AND IT WAS NOTICED THAT THE TIME MOVING FORWARD. 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 10199211 ↗
• MalfunctionJun 24, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER STATED THAT THE CONTACTS ON THE BATTERY CAP AND BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATED THAT THE DISPLAY DID NOT RETURN. 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 10188150 ↗
• MalfunctionJun 18, 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 FEW MOTOR ERRORS AND BUTTON ERRORS. 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 10167021 ↗
• MalfunctionJun 16, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT ACT BUTTON WAS NOT WORKING. CUSTOMER REPORTED THAT THE ACT BUTTON WAS NOT RESPONDING ALL THE TIME, 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 10156673 ↗
• MalfunctionMay 27, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Obstruction of Flow; Power Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP DOWN BUTTON DID NOT WORK. CUSTOMER STATED INSULIN PUP HAD REJECT NEW BATTERIES, LOSES TIME AND DATE SETTING DURING BATTERY CHANGE, NO 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 10091858 ↗
• InjuryMay 26, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPOGLYCEMIA WITH BLOOD GLUCOSE LEVEL WAS 35 MG/DL. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER ALLEGED THAT THE INSULIN PUMP WAS OVER DELIVERING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10086676 ↗
• MalfunctionMay 26, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. TROUBLESHOOTING WAS DONE FOR BLANK DISPLAY. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NEITHER MISSING NOR DAMAGED. DISPLAY DID NOT RETURN AFTER INSERTING NEW BATTERY. 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 10086163 ↗
• MalfunctionMay 17, 2020Battery Problem; Priming Problem; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING OUT WHEN PRIMING. CUSTOMER STATED THAT THE INSULIN PUMP HAD 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 10064237 ↗
• MalfunctionMay 15, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP HAD TO PRESS HARDER AND A TOOK FEW TIME TO RESPOND. CUSTOMER HAD TO CHANGED BATTERY MORE THAN ONCE IN A WEEK. CUSTOMER MENTIONED THAT THEY HAD TO PROGRAM THE TIME AND DATE EVERY TIME WHEN THEY CHANGED THE BATTERIES AND BACKLIGHT WAS DIM. CUSTOMER DECLINED TO TROUBLESHOOTING WITH 24 HOURS HELPLINE. 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 10060563 ↗
• MalfunctionMay 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ANOMALY AND FROZEN DISPLAY. CUSTOMER STATED THAT THE ACT BUTTON WAS NOT RESPONDING AND CLOCK WAS MOVING. 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 10037827 ↗
• MalfunctionMay 7, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THEY WERE ABLE TO CLEAR ALARM 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 10032030 ↗
• InjuryMay 6, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 431 MG/DL. THE CUSTOMER HAD BEEN USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE LEVEL EVENT. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVEL WITH SYRINGES. THE CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT ALLEGE THE INSULIN PUMP FOR UNDER DELIVERY. THE INSULIN PUMP RECEIVED NO DELIVERY ALARMS. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10028305 ↗
• InjuryMay 6, 2020Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 532 MG/DL. THE CUSTOMER WAS REPORTED THAT THE INSULIN PUMP HAD INSULIN FLOW BLOCKED ALARM. EVENT WAS RESOLVED BY COMPLETE SET CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10027707 ↗
• MalfunctionApr 30, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP'S BUTTONS WERE LESS RESPONSIVE. CUSTOMER STATED THE INSULIN PUMP HAD RANDOM NO DELIVERY AND LONGER ON REWIND. 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 10014298 ↗
• MalfunctionApr 28, 2020Device Alarm System; Failure to Cycle; Mechanical Problem; Device Alarm System; Failure to Cycle; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCED SENSOR SYSTEM ERROR WHICH WAS RESOLVED BY REMOVING AND REPLACING THE BATTERY, HAD MOTOR ERROR ALARMS AND WOULD GET THE LOW RESERVOIR WARNING ONLY OCCASIONALLY. 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 10007639 ↗
• MalfunctionApr 27, 2020Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Power Problem; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND FROZEN DISPLAY. CUSTOMER STATED THAT THEY RECEIVED BATTERY OUT LIMIT. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THE TIME CLOCK WAS ADVANCED. 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 10001038 ↗
• MalfunctionApr 20, 2020Power Problem; Patient Device Interaction Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL FAILED BATTERY TEST ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. 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 9977924 ↗

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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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