Paradigm® REAL-Time Revel™ MMT-723RNAS (UDI 00613994748751)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00613994748751), received between Jun 1, 2017 and Oct 8, 2020 — classified as 1 death, 16 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (8 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS CORRECT. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO DROPPED OR BUMPED. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. 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 10653815 ↗
• MalfunctionNov 27, 2019Device Alarm System; Obstruction of Flow; Power Problem; Device Alarm System; Obstruction of Flow; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS COMPLETELY OFF AND NOT GETTING LOW BATTERY WARNING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP REJECTED BATTERIES AND NO DELIVERY ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9381282 ↗
• MalfunctionOct 24, 2019Device Difficult to Program or Calibrate; Priming Problem; Device Difficult to Program or Calibrate; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS THAT WERE HARD TO PRESS. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT PRIMING AT TIMES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9231296 ↗
• MalfunctionOct 9, 2019No Display/Image; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Patient Device Interaction Problem; No Display/Image; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE HARDER AND TAKES FEW TIME TO RESPOND. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RECEIVED A ERROR CODE MESSAGE, CRACKED SCREEN NEAR THE RESERVOIR COMPARTMENT AND INSULIN PUMP LOCKED AND WAS UNRESPONSIVE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9171115 ↗
• MalfunctionSep 17, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNKNOWN ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9074207 ↗
• MalfunctionAug 1, 2019Premature Discharge of Battery; Unexpected Shutdown; Premature Discharge of Battery; Unexpected Shutdown

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 214 MG/DL. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT THEY HAD PERFORMED THE SELF TEST AND THE TEST WAS PASSED. THE TROUBLESHOOTING WAS PERFORMED FOR PUMP ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849282 ↗
• MalfunctionJul 29, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTON ERROR ALARM AND ESC AS WELL AS ACT BUTTONS WERE NOT RESPONDING. CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THEY WERE NOT ABLE TO CLEAR THE ALARM. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8835268 ↗
• MalfunctionMar 16, 2019No Display/Image; No Display/Image

  CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT WORKING RIGHT. CUSTOMER BLOOD GLUCOSE LEVEL WAS 160 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTIONS. THE CUSTOMER WAS DECLINE TROUBLESHOOTING FOR LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8427058 ↗
• InjuryFeb 22, 2019Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 50 MG/DL AT THE TIME OF THE INCIDENT, 96 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER WILL NOT BE RETURNED INSULIN PUMP FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360867 ↗
• MalfunctionFeb 15, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE STICKING MULTIPLE TIMES A DAY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343063 ↗
• InjuryJan 28, 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 THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8280598 ↗
• MalfunctionDec 19, 2018Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCED SENSOR SYSTEM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP AND INSULIN SQUIRTED OUT IF THE TUBING DURING MANUAL PRIME. THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED TO HOLD DOWN THE ACT BUTTON UNTIL RECEIVING A SECOND SERIES OF BEEPS AND/OR NUMBERS APPEAR ON THE DISPLAY. THE CUSTOMER STATED THAT THEY DID NOT RECEIVE THE BEEPS NOR DID THE NUMBERS APPEAR ON THE SCREEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183114 ↗
• MalfunctionOct 11, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME FILL ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT INSULIN SQUIRTS DURING THE PRIMING. CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER STATES THAT INSULIN PUMP HAD DIMINISHED BATTERY LIFE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7956485 ↗
• InjurySep 27, 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. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 597 MG/DL AT THE TIME OF INCIDENT. CUSTOMER OTHER RELEVANT BLOOD GLUCOSE LEVEL WAS 598, 590, 400, 450, 500 MG/DL. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7913752 ↗
• InjurySep 26, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 1700 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THE INSULIN PUMP STOPPED WORKING AND IT STOPPED GIVING INSULIN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7909125 ↗
• MalfunctionSep 20, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 135 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 7896366 ↗
• MalfunctionSep 14, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 197 MG/DL AT THE TIME OF INCIDENT. INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR ALARM. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7876635 ↗
• DeathSep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN AN ASSISTED LIVING CENTER. THE CALLER STATED THE DEATH CERTIFICATE WAS NOT AVAILABLE YET. THE CALLER STATED THAT THE CAUSE OF DEATH IS STILL UNKNOWN. THE CALLER STATED THAT THE CUSTOMER WENT TO SLEEP AND DID NOT WAKE UP. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER DID NOT HAVE ANY HEALTH ISSUES THAT MAY HAVE LED TO THE PASSING. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 7859013 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 15 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER'S WIFE NOTICED THE CUSTOMER WAS PASSED OUT, PRIOR TO RECEIVING MEDICAL ASSISTANCE. THE CUSTOMER WAS TREATED WITH DEXTROSE. TROUBLESHOOTING WAS NOT COMPLETED FOR THE INSULIN PUMP. THE CUSTOMER WAS CURRENTLY EXPERIENCING HIGH BLOOD GLUCOSE OF 308 MG/DL DUE TO BEING OFF THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7849964 ↗
• MalfunctionAug 27, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEN INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821014 ↗
• MalfunctionAug 22, 2018Display or Visual Feedback Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM, UNEXPECTED RESTART ALARM AND EXTERNAL RAM CRC ERROR ALARM ON THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THE INSULIN PUMP HAD MULTIPLE ALARMS AND THE ISSUES REMAINED UNRESOLVED. 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 Known Impact Or Consequence To Patient

  MAUDE report 7807318 ↗
• MalfunctionJul 31, 2018Human-Device Interface Problem; Human-Device Interface Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS MAKING NOISE DURING THE REWIND PROCESS AND INSULIN PUMP HAD A TIME CLOCK ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. IT WAS ALSO STATED THAT THE BATTERY CAP WAS DAMAGED. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7735297 ↗
• InjuryJul 11, 2018Device Alarm System; Device Alarm System

  CUSTOMER REPORTED VIA PHONE CALL BEEP ANOMALY ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 316 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THEY WERE UNABLE TO HEAR THE BEEP AND ALLOWED THE INSULIN PUMP TO REST HOWEVER THE ISSUE REMAINED UNRESOLVED. 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: Hyperglycemia

  MAUDE report 7676527 ↗
• MalfunctionJun 27, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER REPORTED A MOTOR POSITION ENCODER ERROR. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE 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 7642392 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE WAS 245MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS OVER 373MG/DL. CUSTOMER WAS EXPERIENCED SYMPTOMS LIKE, DIFFICULTY BREATHING. CUSTOMER WAS TREATED WITH INSULIN PUMP. TROUBLESHOOTING WAS DONE. BASED ON CUSTOMER REPORT CUSTOMER DID NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7629939 ↗

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