Paradigm® REAL-Time Revel™ MMT-723RNAP (UDI 00643169221499)Recalls & reported problems

Summary

The FDA's MAUDE database contains 209 adverse event reports that list this exact device (DI 00643169221499), received between May 23, 2017 and Jul 20, 2020 — classified as 2 deaths, 74 injuries, 133 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (41 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 209 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 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 DRIVE CAP WAS STICKING OUT. CUSTOMER REPORTED CYCLE FAILULAR ALARM AND BEFORE THAT INSULIN PUMP WAS DROPPED. THE 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 10293894 ↗
• MalfunctionJul 19, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR. CUSTOMER STATED THE THEY CAN NOT GET THE INSULIN PUMP TO RESPOND TO BUTTON PRESSES. 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 10293729 ↗
• MalfunctionJul 13, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR ALARM. THE DRIVE SUPPORT CAP SUPPORT CAP APPEARED 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 10262984 ↗
• InjuryJun 3, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 442 MG/DL. THE CUSTOMER STATED THAT THEY WERE TREATED WITH INSULIN PUMP. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER DID ALLEGED INSULIN PUMP WAS UNDER DELIVERING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10113723 ↗
• MalfunctionDec 24, 2019Failure to Cycle; Detachment of Device or Device Component; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE ALARM OCCURRING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 9514909 ↗
• MalfunctionDec 23, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT THE BUTTONS WERE HARDER TO PRESS AND NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9509733 ↗
• InjuryDec 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 600 MG/DL. THE CUSTOMER WAS TREATED WITH 10 UNITS OF INSULIN FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9408119 ↗
• MalfunctionNov 18, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD FROZEN DISPLAY. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS NOT ABLE TO CLEAR ALARM. CUSTOMER STATED THAT THE TIME WAS NO ADVANCING. CUSTOMER WAS NOT CALLING BACK WITH FROZEN DISPLAY AFTER INSTALLING A NEW BATTERY FOR PREVIOUS FROZEN DISPLAY ISSUE. THE CUSTOMER WAS ADVISED 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 9339482 ↗
• MalfunctionOct 31, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THE BATTERIES WERE OUT OF INSULIN PUMP GREATER THAN DURATION ALLOWED BY THE INSULIN PUMP. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM AND THEY DID NOT RECEIVE A REQUEST TO REWIND INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9259248 ↗
• MalfunctionOct 2, 2019Failure to Cycle; Detachment of Device or Device Component; Material Integrity Problem; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Material Integrity Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCED SENSOR SYSTEM ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 159 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN WAS SQUIRTING OUT DURING MANUAL PRIMING. THE CUSTOMER MENTIONED THAT THE BATTERY CAP HAD A CRACK ON THE TOP AND SHE USED TO GLUE IT BACK AND USED IT FOR A MONTH. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THEY ARE STUCK IN REWIND COMPLETE AND BOLUS DELIVERY LOOP. THEY STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9143923 ↗
• InjurySep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED FOR SURGERY AND NOT DIABETES RELATED. THE CUSTOMER REMOVED THE INSULIN PUMP DUE TO SURGERY AND WAS OFF THE INSULIN PUMP FOR WEEK AFTER THE SURGERY.

  Patient problems: Complaint, Ill-Defined; Hyperglycemia; Hypoglycemia

  MAUDE report 9132844 ↗
• MalfunctionSep 30, 2019Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD UNEXPLAINED MOTOR ERRORS AND SLOW TO REWIND. 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 9132794 ↗
• MalfunctionSep 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY INSULIN PUMP HAD STUCK BUTTONS ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 272 MG/DL. THE CUSTOMER WAS DECLINED TO TROUBLESHOOTING. CUSTOMER STATED THAT THEY OBSERVED TIME CLOCK FOR ONE MINUTE TO TIME ADVANCED. 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 HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081441 ↗
• MalfunctionSep 12, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTONS WERE HARDER TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND ISSUE WITH SEEING THE SCREEN PROPERLY. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9003096 ↗
• MalfunctionSep 11, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SOMETIMES THE SCREEN GOES BLANK AND THEY HAD TO PLAY WITH THE BATTERIES TO GET THE INSULIN PUMP TO WORK AGAIN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. 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 DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8993066 ↗
• InjurySep 11, 2019Failure to Cycle; No Apparent Adverse Event; Failure to Cycle; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S HIGH BLOOD GLUCOSE LEVEL WAS 592 MG/DL. IT WAS REPORTED THAT INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ERROR ALARM. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT INSULIN WAS "SQUIRTING OUT" DURING THE MANUAL PRIME PROCESS AND DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8987419 ↗
• InjuryAug 19, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 48 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN GLUCOSE TABLETS AND INTRAVENOUS FLUIDS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS BEING UNRESPONSIVE. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED GETTING SOME ERROR MESSAGES. TROUBLESHOOTING WAS COMPLETED AND NO ISSUES WERE FOUND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8905436 ↗
• MalfunctionAug 14, 2019Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; No Apparent Adverse Event; Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCREEN DIFFICULT TO READ. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP WAS RECEIVED RANDOM NO DELIVERY ALARM AND DID NOT RECEIVED LOW BATTERY WARNING. CUSTOMER STATED THAT BATTERY WAS OUT LONGER THAN 5 MINUTE AND INSULIN PUMP REJECT NEW BATTERY EVERY TIME. CUSTOMER REPORTED THAT FAILED BATTERY TEST BEFORE EVERY TIME THEY CHANGE THE BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891831 ↗
• MalfunctionAug 14, 2019Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 239 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED/ LOOSE/STICKING OUT. 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 8891723 ↗
• MalfunctionAug 13, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP KEYPAD WAS UNRESPONSIVE AND BUTTON ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 236 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATE THAT THE CANNOT EXIT OUT FROM THE ALERT OR ALARM. THE CUSTOMER STATED THAT 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 Consequences Or Impact To Patient

  MAUDE report 8887883 ↗
• MalfunctionAug 13, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ESCAPE BUTTON OF INSULIN PUMP WORKS INTERMITTENTLY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER DECLINED TROUBLESHOOTING WITH TECHNICAL SUPPORT. THE DEVICE WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887659 ↗
• MalfunctionAug 13, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA VOICEMAIL THAT HER INSULIN PUMP WAS NOT WORKING AT ALL. 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 8886944 ↗
• MalfunctionAug 9, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP CASE WAS CRACKED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8878240 ↗
• MalfunctionAug 7, 2019Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S SCREEN WAS FREEZES AT TIMES ELEVEN. 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 8867904 ↗
• MalfunctionAug 2, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Material Integrity Problem; Power Problem; Priming Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Material Integrity Problem; Power Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SQUIRT INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BATTERIES QUICKER THAN IT USED TO, REWIND OR PRIME LOUDER, BATTERY CAP INDENTATION, REJECTED NEW BATTERY AND UNEXPLAINED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8854327 ↗

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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-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