Paradigm® REAL-Time Revel™ MMT-723LNAB (UDI 00643169513877)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,243 adverse event reports that list this exact device (DI 00643169513877), received between May 12, 2017 and Mar 26, 2021 — classified as 10 deaths, 524 injuries, 709 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (205 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 1,243 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MED INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER HAD ISSUES WHERE WHEN HE PUTS BATTERY IN THE PUMP WONT RECOGNIZE IT AND HE HAS TO CHANGE THEM SEVERAL TIMES. CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS NORMAL, INSULIN PUMP WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD AND DECLINED MOTOR POSITION ENCODER ERROR ALERT. CUSTOMER WAS ABLE TO CLEAR AND ABLE REWIND THE INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11573310 ↗
• MalfunctionFeb 14, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Insufficient Information

  MAUDE report 11326291 ↗
• MalfunctionAug 10, 2020Mechanical Problem; Environmental Compatibility Problem; Mechanical Problem; Environmental Compatibility Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THEY WERE UNABLE TO CLEAR THE ALARM AND THEY WERE UNABLE TO REWIND INSULIN PUMP. CUSTOMER STATED DRIVE SUPPORT CAP WAS PROTRUDED. CUSTOMER STATED INSULIN PUMP WAS EXPOSED TO MOISTURE. TROUBLESHOOTING WAS 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 10384076 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER ALSO REPORTED BENT CANNULA. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10360993 ↗
• MalfunctionAug 4, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT 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 10360934 ↗
• InjuryJul 30, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 850 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM WHICH THEY CLEARED AND THEN THEY WERE GETTING NO DELIVER ALARMS. THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10342568 ↗
• MalfunctionJul 29, 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 HAD UP ARROW WERE HARDER TO PRESS, NO DELIVERY ALARM, HAD TO REWIND MORE THAN ONCE. 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 10337019 ↗
• InjuryJul 28, 2020Adverse 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'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 500 MG/DL. CURRENT BLOOD GLUCOSE LEVEL IS 557 MG/DL. OTHER BLOOD GLUCOSE VALUE MENTIONED SUCH AS OVER 500 MG/DL, 200 MG/DL, 270 MG/DL, 395 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN SHOT AND FLUIDS IN AN INTRAVENOUS IN THE HOSPITAL. THE CUSTOMER WAS USING THE INSULIN PUMP WITHIN 48 HOURS OF HIGH BLOOD GLUCOSE EVENT. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10330799 ↗
• MalfunctionJul 24, 2020Premature Discharge of Battery; No Display/Image; Premature Discharge of Battery; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR AND ALSO HAD BLANK DISPLAY. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP HAD RECURRING INSULIN PUMP ERROR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER DECLINED TROUBLESHOOTING FOR BLANK DISPLAY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10318563 ↗
• MalfunctionJul 23, 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 BUTTONS WERE NO RESPONSIVE. CUSTOMER STATED THAT THE INSULIN PUMP HAD 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 10313441 ↗
• MalfunctionJul 23, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A PARTIAL DISPLAY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THERE WAS A BLACK LINE ON THE DISPLAY AND THEY HAD DIFFICULTY READING THE DISPLAY SCREEN. CUSTOMER STATED THE BATTERY WAS CHANGED BUT THE ISSUE WAS NOT RESOLVED. 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 10313396 ↗
• InjuryJul 22, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE TREATED BY EMERGENCY MEDICAL SERVICES AS THEY HAD LOW BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 24 MG/DL, AT THE TIME OF INCIDENCE. CUSTOMER REPORTED THAT THEY TREATED WITH GLUCAGON AND FOOD . CUSTOMER REPORTED THAT THE INSULIN PUMP DELIVERED LARGE AMOUNT OF INSULIN OVER NIGHT TO THEM AND THEY HAD LOW BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE LEVEL. IT WAS UNKNOWN IF THE CUSTOMER WAS USING AUTO MODE AT THE TIME OF EVENT. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10306680 ↗
• MalfunctionJul 22, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD RESERVOIR LOCK ON THE TOP OF THE WAS COMPLETELY BROKEN OFF, BATTERY COMPARTMENT WAS MISSING PIECES AND WAS GONE AS WELL AS THAT ONLY THE RUBBER SEAL WAS THERE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT INSULIN PUMP REJECTED RECHARGEABLE BATTERIES ON OCCASION. THE QUICK SET WAS LEAKED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10306672 ↗
• MalfunctionJul 19, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND BUTTONS WERE STUCK. CUSTOMER STATED INSULIN PUMP SOMETIMES NOT REWIND ALL THE WAY AND CRACK ON RESERVOIR SIDE. 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 10293793 ↗
• MalfunctionJul 15, 2020Mechanical Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Material Integrity Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCRATCHES ON SCREEN MIGHT CAUSE IT HARD TO READ AT TIMES. CUSTOMER STATED THE INSULIN PUMP HAD REJECTED NEW BATTERY, SLOWER DURING REWIND, LOUDER DURING REWIND AND BATTERY CAP WAS WORN OUT MADE IT HARD TO GET THE BATTERY OUT. 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 10274397 ↗
• MalfunctionJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. THE CUSTOMER STATED THAT THEY WERE STUCK IN THE FILL TUBING PROCESS. THE CUSTOMER CHANGED BATTERY AND DID THE SET CHANGE. 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 10249527 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 452 MG/DL, 311 MG/DL, 353 MG/DL AND 402 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10232048 ↗
• MalfunctionJun 26, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT UNABLE TO 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 10198301 ↗
• MalfunctionJun 23, 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. CUSTOMER REPORTED THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 10183623 ↗
• MalfunctionJun 19, 2020Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UP AND DOWN ARROW BUTTON STUCK. CUSTOMER STATED THE INSULIN PUMP HAD FAILED BATTERY TEST AND SCRATCHES ON SCREEN. 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 10172370 ↗
• MalfunctionJun 2, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER WAS ALSO REPORTED THAT INSULIN PUMP SCREEN HAD SCRATCHES. 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 10113399 ↗
• MalfunctionMay 27, 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 BUTTONS DID NOT WORK PROPERLY, HAD TO KEEP PRESSING THEM ESPECIALLY THE UP AND DOWN BUTTONS HAD AN UNEXPLAINED NO DELIVERY ALARM AND MOTOR WAS A LITTLE LOUDER. 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 10091125 ↗
• MalfunctionMay 26, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARMS. THE CUSTOMER STATED THAT THE INSULIN PUMP SCREEN HAD BLUE OR GREEN DISCOLORATION. INSULIN PUMP HAD CRACKS IN RESERVOIR WINDOW CASING. 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 10086618 ↗
• MalfunctionMay 22, 2020Computer Software Problem; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Computer Software Problem; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP ACT BUTTON WAS NOT RESPONDING AND HAD FROZEN DISPLAY. CUSTOMER STATED THEY CHANGED THE BATTERY ON INSULIN PUMP AND GOT SOFTWARE ERROR BAD POINTER. 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 10081431 ↗
• MalfunctionMay 19, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD CRACKED ON BATTERY COMPARTMENT AND NEAR THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT RESERVOIR UNABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10069957 ↗

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-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-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-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-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-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