Paradigm® REAL-Time Revel™ MMT-723NAL (UDI 00643169693791)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169693791), received between Jan 10, 2018 and May 28, 2020 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (3 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2020Patient Device Interaction Problem; Priming Problem; Patient Device Interaction Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP WAS STUCK IN FILL TUBING. CUSTOMER REPORTED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. INSULIN PUMP HAD CRACK ON SCREEN. 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 10095430 ↗
• InjuryJan 21, 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 MOTHER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE AND NO DELIVERY ALARM. . BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 525 MG/DL. CUSTOMER'S MOTHER DECLINED TO TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE REPLACED, AND CUSTOMER DID NOT AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9609379 ↗
• MalfunctionNov 16, 2019Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STICKY BUTTONS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT BATTERY THREADING WAS STRIPPED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9332775 ↗
• MalfunctionOct 2, 2019Mechanical Problem; Use of Device Problem; Power Problem; Mechanical Problem; Use of Device Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD TO REWIND MORE THAN ONCE DURING PRIMING AND INSULIN PUMP HAD GETTING ALARM TO RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT INSULIN PUMP REJECTED NEW BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144226 ↗
• MalfunctionSep 30, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP DOWN AND ACT BUTTON WAS HARDER AND THEN INSULIN PUMP FOR RESPOND . THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. INSULIN PUMP HAD SQUIRTED INSULIN DURING PRIMING AND REWIND PROCESS WAS LOUDER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132801 ↗
• InjurySep 27, 2019Adverse 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 HAD A HIGH BLOOD GLUCOSE VALUE OF 429 MG/DL. CUSTOMER STATED THAT THEY WAS STRUGGLING WITH CHANGING OUT INFUSION SET AND THEY TOOK A BOLUS AND REFUSED TO TROUBLESHOOT FOR HIGH BLOOD SUGAR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9129956 ↗
• MalfunctionSep 12, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER¿S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 190 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE INSULIN PUMP REWIND. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REFER TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9004046 ↗
• MalfunctionMay 27, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES THAT INSIDE THE RESERVOIR RING WAS SHATTERED. CUSTOMER STATES THAT RESERVOIR AREA AND THE METAL PIECE INSIDE THE BATTERY CAP WAS CRACK. CUSTOMER STATES THAT RESERVOIR UNABLE LOCK IN PLACE. 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 8643593 ↗
• InjuryMay 9, 2019Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND ALSO INSULIN PUMP WAS NOT WORKING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 398 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, ABDOMINAL PAIN, FELT SICK. CUSTOMER HAD USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED WITH MANUAL SHOT AND INSULIN DRIP. CUSTOMER ALLEGING INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Fatigue; Hyperglycemia; Nausea

  MAUDE report 8594980 ↗
• InjuryApr 26, 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 THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 270 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8554089 ↗
• MalfunctionFeb 14, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP UP AND DOWN BUTTONS WERE LESS RESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8341904 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED ON (B)(6) 2018 WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS ABOUT THIS INCIDENT. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER ALSO HAD A LOW OF 3 MG/DL AROUND (B)(6) 2018. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8008298 ↗
• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE AROUND (B)(6) 2018 WITH BLOOD GLUCOSE OF 3 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FEELING UNWELL, SHAKINESS, DIZZINESS, DISCOMFORT, FLUID OVERLOAD, AND LETHARGY. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER HAD DIALYSIS COMPLICATIONS. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER WAS ALSO HOSPITALIZED ON (B)(6) 2018. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8008192 ↗
• InjuryAug 29, 2018Adverse 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 418 MG/DL AND THAT THE INSULIN PUMP WAS ALARMING NO DELIVERY. THE CUSTOMER REPORTED THAT THEY HAD RECEIVED A REPLACEMENT PUMP DUE TO EXCESSIVE NO DELIVERY ALARMS AND BELIEVES THE ISSUE TO BE RELATED TO THE INFUSION SETS. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. THE CUSTOMER DID NOT HAVE AN ADDITIONAL INFUSION SET AVAILABLE TO PERFORM TROUBLESHOOTING. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET, RESERVOIR AND INSULIN AND TO TREAT PER HEALTHCARE PROFESSIONAL'S RECOMMENDATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7830869 ↗
• InjuryAug 1, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD NO DELIVERY ALARM. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 483 MG/DL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7738028 ↗
• MalfunctionJul 17, 2018Insufficient Flow or Under Infusion

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP WAS OVER AND UNDER DELIVERING AS THEY WERE GOING EITHER TOO HIGH OR TOO LOW. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT, AND 80 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER HAD FILLED THE RESERVOIR THE PREVIOUS NIGHT AND NOW HAD ABOUT 150 UNITS LEFT, BUT THEY HAD NOT BLOUSED THAT MUCH THAT DAY. TROUBLESHOOTING WAS COMPLETED FOR THE LOWS BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7693468 ↗
• MalfunctionMay 29, 2018No Display/Image; Device Inoperable

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY AS INSULIN PUMP WAS NOT WORKING .THE CUSTOMER¿S BLOOD GLUCOSE LEVEL 88MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT THE PUMP WAS NOT EXPOSE TO MOISTURE .THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7548388 ↗
• MalfunctionMay 28, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT CUSTOMER WAS NOT ABLE TO REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER WAS ADVISED TO CHANGE COMPLETE SET. THE INSULIN PUMP WILL BE RETURNED BE FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7547370 ↗
• MalfunctionMar 16, 2018Incorrect Or Inadequate Test Results; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED THE FAILED BATTERY TEST. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 194 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A NO DELIVERY ALARM BUT IT WAS RESOLVED. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7347267 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 546 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7180873 ↗

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-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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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