Paradigm® REAL-Time Revel™ MMT-523LNAS (UDI 00643169932982)Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00643169932982), received between Dec 19, 2017 and Jul 30, 2020 — classified as 32 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (20 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 25 most recent of 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2020Insufficient Flow or Under Infusion; Detachment of Device or Device Component; Insufficient Flow or Under Infusion; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY ALLEGE INSULIN PUMP WAS UNDER DELIVERING AND DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND WAS TREATED WITH MANUAL INJECTION. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Blood Loss; Hyperglycemia

  MAUDE report 10342897 ↗
• MalfunctionJul 17, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS NO RESPONSE FROM ACT BUTTON. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND IT ADVANCE. 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 10287797 ↗
• MalfunctionJul 14, 2020Device Difficult to Program or Calibrate; Connection Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE NON RESPONSIVE AND STICKY AND THE RESERVOIR DID NOT COMPLETELY LOCK BECAUSE OF THE STRIPPED RING. THE CUSTOMER DECLINED TROUBLESHOOTING. 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 10269034 ↗
• MalfunctionJun 3, 2020Premature Discharge of Battery; Loss of Data; Premature Discharge of Battery; Loss of Data

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PUMP ERROR SHORTLY AFTER INSERTING A NEW BATTERY. THE CUSTOMER WAS PREVIOUSLY ABLE TO CLEAR THE ALARM AND ABLE 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 10113452 ↗
• MalfunctionMay 8, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD UNEXPECTED RESTART, A COLD RESET WAS PERFORMED ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER NOT ABLE TO COMPLETE REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10039781 ↗
• InjuryApr 22, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 528 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER WAS ABLE TO CLEAR ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9984715 ↗
• MalfunctionApr 3, 2020Device Difficult to Program or Calibrate; Connection Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE TOP OF THE RESERVOIR CHIPPED AND THE RING CAME OFF WHEN SHE WAS PUTTING THE RESERVOIR BACK INTO INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER STATED THE BUTTONS ARE GETTING HARDER AND HARDER TO PRESS. CUSTOMER STATED THAT IT WAS A COMBINATION OF THE INSULIN PUMP AND HER ARTHRITIS. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9920287 ↗
• MalfunctionFeb 26, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. CUSTOMER ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER DID NOT REPORTING ABOUT MOTOR POSITION ENCODER ERROR. CUSTOMER STATED THAT THE INSULIN PUMP ALARM HISTORY CONTAINS NEITHER MOTOR POSITION ENCODER ERROR ALARM NOR MORE THAN ONE MOTOR ERROR WITHIN LAST 30 DAYS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9754599 ↗
• MalfunctionFeb 12, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BUTTON ARE LESS RESPONSIVE AND HARDER TO PRESS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9698653 ↗
• MalfunctionDec 29, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 177 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO STATED THAT HISTORY INSULIN PUMP RECEIVED MOTOR ERROR ENCODE ALARM NOR MORE THAN ONE MOTOR ERROR ALARM WITHIN THE LAST 30 DAYS AND THEY WERE UNABLE TO COMPLETE PUMP REWOUND DUE TO PUMP ALARM. 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. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9528786 ↗
• MalfunctionNov 30, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Insufficient Device Problem Information; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THE SOMETIMES BUTTONS OF INSULIN PUMP WAS STICK ALSO INSULIN PUMP RECEIVED THE PUMP ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT INSULIN PUMP RECEIVED RANDOM NO DELIVERY ALARMS AND IT WAS CORRECTED BY ESC OR ACT BUTTON. CUSTOMER ALSO STATED THAT THEY HAD TO RESET DATE AND TIME DURING BATTERY CHANGE ALSO SOMETIMES INSULIN PUMP REJECTS BATTERIES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9392229 ↗
• InjuryNov 13, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY EXPERIENCED HYPOGLYCEMIA AS WELL AS HYPERGLYCEMIA. CUSTOMER'S HIGH BLOOD GLUCOSE VALUE WAS 523 MG/DL AND LOW BLOOD GLUCOSE VALUE WAS 53 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE INSULIN EXITED. CUSTOMER STATED THAT IT WAS DURING A BOLUS SHE CHANGED THE SET AND IT WAS STILL GIVING HER NO DELIVERY ALARM. CUSTOMER WAS REPORTING A PAST EVENT. CUSTOMER REPORTS ALARM DID NOT OCCUR DURING MANUAL PRIME. CUSTOMER REPORTED EVENT WAS RESOLVED BY CHANGING COMPLETE SET. THE CUSTOMER STATED THAT CANNULA WAS NOT BENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9314299 ↗
• MalfunctionNov 1, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT CRACK AT BATTERY COMPARTMENT. CUSTOMER¿S BLOOD GLUCOSE WAS 194 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265172 ↗
• MalfunctionOct 30, 2019Device Alarm System; Premature Discharge of Battery; Patient Device Interaction Problem; Device Alarm System; Premature Discharge of Battery; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMS ARE DIMINISHED IN SOUND. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF THE INCIDENT. THE CUSTOMER HAD SEVERAL ISSUES WITH THE INSULIN PUMP, SCRATCHES ON SCREEN, AND LOSES SETTING WHEN BATTERY IS CHANGED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254350 ↗
• MalfunctionOct 4, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RING ON THE TOP OF THE RESERVOIR WAS BROKEN. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 243 MG/DL AT THE TIME OF THE INCIDENT. 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 9154655 ↗
• MalfunctionOct 2, 2019Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AUDIO ANOMALY. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER STATED THEY CANNOT HEAR THE BEEPS EVEN THOUGH SETTINGS HAD ADJUSTED. CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9144201 ↗
• MalfunctionSep 20, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  THE CUSTOMER'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS CURRENTLY FROZEN AND THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 324 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097036 ↗
• MalfunctionSep 12, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. CUSTOMER WAS UNABLE TO CLEAR THE ALARM. THE CUSTOMER WAS ALSO 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9002431 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE VALUE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 475MG/DL. CUSTOMER STATED THAT THE INJECTION WAS NOT ENOUGH TO LAST THEM TO LOWER DOWN. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE VALUE. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8968096 ↗
• InjuryAug 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 A HIGH BLOOD GLUCOSE. CUSTOMER¿S HIGH BLOOD GLUCOSE VALUE WAS 400 MG/DL, 487 MG/DL. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS 119 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL NOT RETURN FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8900433 ↗
• MalfunctionAug 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ISSUES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE TIME WAS ADVANCING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8858531 ↗
• MalfunctionJul 25, 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 SONG. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT PUMP HAD HORRIBLE CRACK AND THE CUSTOMER CANT SEE ANYTHING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826361 ↗
• MalfunctionJul 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS DAMAGED AT THE FRONT OF BUTTON. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8806708 ↗
• MalfunctionJul 19, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8806340 ↗
• MalfunctionJul 12, 2019Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SCREEN OF INSULIN PUMP HAD SCRATCHES THAT MAKING IT HARDER TO SEE ALSO INSULIN WAS SQUIRTING DURING PRIMING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER ALSO STATED THAT INSULIN PUMP GAVE BAD BATTERY ALERT ON GOOD BATTERY ALSO RANDOM NO INSULIN DELIVERY ALARMS. THE DEVICE WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783876 ↗

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-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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