Paradigm® REAL-Time Revel™ MMT-723NAL (UDI 00613994743916)Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 00613994743916), received between Jun 6, 2017 and Jun 20, 2023 — classified as 10 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (32 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 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2023Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT MOTOR ERROR ALARM OCCURRED ON THE INSULIN PUMP. CUSTOMER REPORTED THAT DRIVE SUPPORT CAP APPEARED NORMAL (RECESSED). CUSTOMER STATED THAT INSULIN PUMP REWOUND. CUSTOMER CHECKED ALARM HISTORY AND FOUND TWO MOTOR ERROR ALARMS. CUSTOMER REPORTED SECOND OCCURRED ON MOTOR ERROR ALARM. NOR HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163906 ↗
• MalfunctionJul 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER STATED THAT THE BATTERY WAS CORRODED IN INSULIN PUMP AND THEY WERE UNABLE TO GET THE BATTERY OUT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10231605 ↗
• MalfunctionJun 7, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT WAS 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 10126827 ↗
• MalfunctionMay 15, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT ABLE TO DETERMINE THAT THERE WAS A RESERVOIR INSERTED. CUSTOMER REPORTED THAT EVERYTHING WORK STILL AFTER CHANGING THE RESERVOIR. 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 10060737 ↗
• MalfunctionApr 14, 2020Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE PISTON WAS STUCK IN INSULIN PUMP AND INSULIN PUMP WAS GIVING WAY TOO HIGH A BOLUS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP AND RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9960608 ↗
• MalfunctionMar 28, 2020Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM, A MOTOR ERROR, BATTERY ISSUES, AND HAD SCRATCHES ON THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PROVIDED. NO ALARMS WERE CLEARED. NO OTHER INFORMATION WAS PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9892659 ↗
• InjuryMar 5, 2020Adverse 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 LOW BLOOD GLUCOSE LEVEL 41 MG/DL. CUSTOMER WAS TREATED WITH GLUCOSE TABLET. CUSTOMER HAD BLOOD GLUCOSE LEVEL OF 60 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ALLEGING INSULIN PUMP FOR OVER DELIVERING BECAUSE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9791218 ↗
• MalfunctionJan 30, 2020Failure to Cycle; Priming Problem; Failure to Cycle; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS 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 9646244 ↗
• MalfunctionJan 22, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR DOES NOT LOCK IN PLACE AND THE BATTERY ON THE PUMP DOES NOT LAST LONG AND THE SCREEN FREEZES. CUSTOMER ALSO REPORTED THAT THE BATTERY ON THE DOES NOT LAST LONG. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9614804 ↗
• MalfunctionJan 13, 2020Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND SCREEN HARD TO READ. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580477 ↗
• MalfunctionJan 10, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS OVER 300 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER STATED THAT THE INSULIN PUMP WAS ABLE TO REWIND. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9578865 ↗
• MalfunctionNov 13, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313862 ↗
• MalfunctionNov 1, 2019Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NO POWER AFTER BATTERY INSERTED, AFTER BATTERY CHANGE, HAD TO REPROGRAM IN DATE AND TIME IN HISTORY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALERTS AND CRACKED 1 INCH LONG NEAR RESERVOIR CHAMBER AND AROUND BATTERY CAP IN HISTORY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9264854 ↗
• MalfunctionOct 1, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Connection Problem; Power Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Connection Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF INSULIN PUMP HAD TENDENCY TO STICK WHEN PRESSED. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP WAS MAKING AN UNUSUAL NOISE WHEN CHANGED THE RESERVOIR. THE CUSTOMER STATED THAT THE RESERVOIR HAD SOMEWHAT LOOSED IN THE INSULIN PUMP. CUSTOMER STATED THAT THEY WENT THROUGH A LOT BATTERIES AND OCCASIONALLY INSULIN PUMP DID NOT TURN ON WITH NEW BATTERY INSERTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9138859 ↗
• MalfunctionSep 13, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM AND MOTOR POSITION ENCODER ERROR DURING BOLUS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 114 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND WAS RECOMMENDED TO REFER BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9021218 ↗
• MalfunctionAug 26, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS HARD TO PRESS AND STICKY AND UNRESPONSIVE WHEN PRESSED. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT CHANGING BATTERIES EVERY 10-15 DAYS AND NO INSULIN DELIVERY ALARMS WITHOUT EXPLANATION AND ALSO STATED THAT LOUD DURING REWIND. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929380 ↗
• MalfunctionAug 22, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND SOMETIMES DELIVERY ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924083 ↗
• MalfunctionAug 20, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED MOTOR ERRORS, BUTTONS WERE STICKY TO PRESS, GRINDING NOISE, MOTOR WAS LOUDER, DISCOLORATION ON SCREEN, REJECTS NEW BATTERIES AND WORN OUT WHERE THE RESERVOIR WAS PUT IN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8909711 ↗
• MalfunctionJul 1, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8747532 ↗
• MalfunctionJun 14, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS AND INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 238 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS 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 REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8699373 ↗
• MalfunctionJun 10, 2019Mechanical Problem; Mechanical Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8681560 ↗
• MalfunctionMay 28, 2019Display or Visual Feedback Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN THAT EFFECT THE VISIBILITY AND INSULIN SQUIRTING DURING PRIMING RATHER THEN A SLOW DRIP. 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 8645199 ↗
• MalfunctionMay 17, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ISSUE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 340 MG/DL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THAT SHE WERE TRYING TO PUT CARBS IN SO THEY COULD BOLUS AND THE INSULIN PUMP STARTED CYCLING AND CUSTOMER COULD NOT GET IT TO STOP. CUSTOMER RESPONSE BUTTON WERE CONTINUOUS SCROLLING WITHOUT USER INPUT AND NUMBERS KEEP CYCLING. CUSTOMER OBSERVE TIME CLOCK FOR ONE MINUTE WAS ADVANCES. 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 8618804 ↗
• MalfunctionMay 7, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 382 MG/DL. CUSTOMER STATES INSULIN SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATES THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8586559 ↗
• MalfunctionMay 2, 2019No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS NOT TURNING ON. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8573119 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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