Paradigm® REAL-Time Revel™ MMT-723RNAH (UDI 00643169221475)Recalls & reported problems

Summary

The FDA's MAUDE database contains 132 adverse event reports that list this exact device (DI 00643169221475), received between Jun 8, 2017 and Aug 7, 2020 — classified as 59 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (25 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 132 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 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 REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL. CUSTOMER STATED THAT INFUSION SETS THAT DID NOT STICK TO MY BODY. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10379712 ↗
• MalfunctionJun 15, 2020Device Difficult to Program or Calibrate; Use of Device Problem; Power Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. IT WAS STATED THAT THE INSULIN PUMP WAS NOT ACCEPTING NEW BATTERIES, RESETS AND CUSTOMER NEEDS TO UPDATE THE TIME, DATE EVERY TIME SHE CHANGE BATTERY, AND THE ACT BUTTON WAS UNRESPONSIVE IN SEVERAL TIMES. THE CUSTOMER DECLINED TROUBLESHOOTING FOR OLD INSULIN PUMP, BECAUSE SHE ALREADY UPGRADED TO A NEW INSULIN PUMP. 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 10156217 ↗
• MalfunctionMay 6, 2020Battery Problem; Detachment of Device or Device Component; Patient Device Interaction Problem; Battery Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RUBBER WAS WORN DOWN ON BOTTOM OF INSULIN PUMP, CRACK ABOVE THE SCREEN AND BATTERIES WERE LASTING ABOUT WEEK. 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 10029182 ↗
• MalfunctionMar 19, 2020No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THE DISPLAY DID NOT RETURN AFTER INSERTING NEW BATTERY CORRECTLY. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT AFTER BATTERY CHANGE. CUSTOMER DID NOT RECEIVE A REQUEST TO REWIND PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9851958 ↗
• MalfunctionJan 31, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THEY WERE NOT WEARING THE INSULIN PUMP DURING PRIMING. CUSTOMER STATED THAT INSULIN PUMP WAS MAKING A LOT OF NOISE WHEN IT WAS PRIMING. CUSTOMER STATED DRIVE SUPPORT CAP WAS NORMAL. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9650821 ↗
• InjuryJan 23, 2020Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND NO DELIVERY ALARM. BLOOD GLUCOSE READING WAS OVER 700 MG/DL AND OVER 600 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED TAT THEY HAD BLOOD AT SITE AND DECLINED TROUBLESHOOTING FOR THAT. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss; Hyperglycemia

  MAUDE report 9619958 ↗
• MalfunctionJan 3, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S ACT AND ESC BUTTONS WERE NOT WORKING AND WAS HAVING ISSUE WITH PRIMING THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 116 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. 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 9543406 ↗
• MalfunctionJan 3, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRESS BUTTONS MORE THAN ONCE FOR INSULIN PUMP TO RESPOND. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP HAD RANDOM NO DELIVERY ALARM AND CRACK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9542203 ↗
• InjuryDec 16, 2019Adverse 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 700 MG/DL. CUSTOMER STATED THAT THE INFUSION SET TAPE DID NOT STICK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9472227 ↗
• InjuryDec 16, 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 OVER 600 MG/DL. CUSTOMER STATED THAT THE INFUSION SETS WERE NOT STAYING CONNECTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9471236 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF OVER 600 MG/DL. CUSTOMER WAS TREATED WITH SYRINGE. CUSTOMERS STATED THAT INSULIN PUMP ALARMED FOR LOW RESERVOIR. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 9335081 ↗
• MalfunctionOct 23, 2019No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 272 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THE CONTACTS ON THE BATTERY CAP WERE NOT MISSING OR DAMAGED. CUSTOMER STATED THE BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING WAS CORRODED. 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 9226349 ↗
• MalfunctionOct 16, 2019Failure to Cycle; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Failure to Cycle; Display or Visual Feedback Problem; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SHOOTS OUT INSULIN DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP BATTERIES HAD TO REPLACE EVERY 5 DAYS, REJECTS NEW BATTERIES COUPLE TIMES, CHIPPING AROUND BATTERY PORT, BACK LIGHT WAS NO LONGER WORKING, MOTOR WAS SLOWER DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9197256 ↗
• InjuryOct 11, 2019No Display/Image; Mechanical Problem; No Apparent Adverse Event; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 500 MG/DL. CUSTOMER'S OTHER BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT HE WAS ON THE WAY TO THE EMERGENCY ROOM AND HIS INSULIN PUMP HAD COMPLETELY STOPPED WORKING. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR AND CRACKS ON IT. CUSTOMER REPORTED THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER DECLINES TO TROUBLE SHOOT FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9179298 ↗
• InjuryAug 12, 2019Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL IN THE RANGE OF 413MG/DL. CUSTOMER STATED THAT THE BUTTONS WERE NOT RESPONDING AND HAD BUTTON ERROR ALARM. CUSTOMER STATED THAT THE TIME WAS NOT ADVANCING. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8882607 ↗
• MalfunctionJul 22, 2019Failure to Cycle; Use of Device Problem; Priming Problem; Failure to Cycle; Use of Device Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN WAS SQUIRTING OUT DURING FILL TUBING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP RECEIVED RESET ALARM. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810350 ↗
• MalfunctionJun 27, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8738501 ↗
• MalfunctionJun 21, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE STICK. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8721043 ↗
• MalfunctionJun 19, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8711145 ↗
• MalfunctionJun 17, 2019Mechanical Problem; Mechanical Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703267 ↗
• MalfunctionMay 22, 2019No Display/Image; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY AFTER BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8630895 ↗
• InjuryMay 17, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 48 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE WAS 248 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOT FOR LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8618819 ↗
• MalfunctionMay 16, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS TAKE MULTIPLE PRESSES TO RESPOND, RAINBOW EFFECT IN THE SUN WHICH EFFECTS VISIBILITY, INSULIN PUMP REWIND SLOWER THAN IN THE PAST AND UNEXPLAINED NO DELIVERY ALARMS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER DECLINED TO TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615087 ↗
• MalfunctionMay 6, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING PRIMING. CUSTOMER STATED THAT THE INSULIN PUMP SCREEN WAS SCRATCHED UP AND CLOUDY. CUSTOMER STATED THAT THE ACT BUTTON WAS HARD TO PRESS. CUSTOMER STATED THAT THE REWIND WAS SLOWER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581850 ↗
• MalfunctionMay 6, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. THE CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THEY RECEIVED ALARM AFTER BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8581084 ↗

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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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