Paradigm® REAL-Time Revel™ MMT-523NAH (UDI 00643169507173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 385 adverse event reports that list this exact device (DI 00643169507173), received between May 8, 2017 and Nov 28, 2023 — classified as 1 death, 145 injuries, 239 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (83 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 385 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2023Break; Break

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER REPORTED AN ISSUE WITH THE PUMP'S BATTERY LIFE. TROUBLESHOOTING WAS PERFORMED AND HAD A CRACK IN THE PUMP BATTERY COMPARTMENT. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE CUSTOMER WILL DISCONTINUE USING THE DEVICE AND THE PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18214376 ↗
• MalfunctionOct 13, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS DAMAGED, BROKEN AND CLIP WAS OFF. THE CUSTOMER STATED THAT THE NO PHYSICAL DAMAGE TO RETAINER RING. 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 10675782 ↗
• MalfunctionSep 21, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM DURING PRIMING. THEY WERE ABLE TO CLEAR THE ALARM AND REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARED 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 10558889 ↗
• MalfunctionAug 18, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPLAINED RANDOM NO DELIVERY ALARMS. CUSTOMER DECLINED TROUBLESHOOTING. 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 10420177 ↗
• MalfunctionAug 5, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SQUIRT INSULIN WHILE PRIMING, MOTOR ERRORS AND ACT BUTTON WAS HARDER TO PRESS. CUSTOMER STATED THE INSULIN PUMP HAD SOMETIMES LOW BATTERY ALARM, LOST SETTING AND BATTERY WAS NOT OUT MORE THAN 5 MINUTES. 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 10366190 ↗
• MalfunctionJul 29, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR AND MINOR SCRATCHES ON THE SCREEN. 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 10337431 ↗
• MalfunctionJul 24, 2020Computer Software Problem; Patient Device Interaction Problem; Computer Software Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP DID NOT CALCULATE BOLUS INSULIN DOSAGE CORRECTLY ONCE. CUSTOMER STATED THAT SCREEN WAS DAMAGE. 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 10318461 ↗
• MalfunctionJul 22, 2020Obstruction of Flow; Connection Problem; Patient Device Interaction Problem; Obstruction of Flow; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD DIFFICULTY SCREWING IN THE RESERVOIR AND SOMETIMES WOULD TAKE 3 TO 4 TIMES FOR IT TO WORK. CUSTOMER STATED THE INSULIN PUMP HAD UNEXPLAINED NON DELIVERY ALARMS. 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 10306681 ↗
• MalfunctionJul 13, 2020Battery Problem; Power Problem; Battery Problem; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BATTERY FAILED ERROR. THE CUSTOMER STATED INSULIN PUMP HAD BATTERY LASTING FOR 7 DAYS ONLY. 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 10263024 ↗
• InjuryJul 9, 2020Adverse 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 WERE 492 MG/DL AND 488 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE VALUE WAS 159 MG/DL. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER HAD ABDOMINAL PAIN. CUSTOMER TREATED WITH INTRAVENOUS INSULIN DRIP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Hyperglycemia

  MAUDE report 10249717 ↗
• MalfunctionJul 6, 2020Mechanical 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

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD HARD TO PRESS BUTTON. THE CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALERTS AND SLOWER DURING REWIND ALSO CRACKED BATTERY CAP, CRACK UNDER ACT BUTTON WITH CHANGING BATTERY MORE FREQUENTLY. 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 10237849 ↗
• MalfunctionJul 6, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS WERE LESS RESPONSIVE AND HARDER TO PRESS. 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 10232202 ↗
• MalfunctionJul 1, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERRORS, RANDOM AND UNEXPLAINED NO DELIVERY ALARMS AND MOTOR SOMETIMES MADE GRINDING AND SCREECHING NOISES. THEY MENTIONED THAT THE INSULIN PUMP NOT ALWAYS DELIVERED INSULIN. 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 10216782 ↗
• MalfunctionJun 26, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DRIVE SUPPORT CAP APPEARS PROTRUDED. 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 10199593 ↗
• InjuryJun 24, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO UNKNOWN REASON ON DATE WITH UNKNOWN BLOOD GLUCOSE LEVEL. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP GAVE THEM A LOT OF INSULIN AND MALFUNCTION HAPPENED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10187524 ↗
• InjuryJun 5, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE VISITED TO EMERGENCY ROOM THEN HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON LAST END OF MAY TO JULY WITH BLOOD GLUCOSE OF 300 MG/DL TO 450 MG/DL. THE CUSTOMER WAS TREATED WITH DRIP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. CUSTOMER REPORTED THAT THE UP AND DOWN BUTTONS WERE HARD TO GOT A RESPONSE AND BATTERY COMPARTMENT WAS CRACKED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10122229 ↗
• MalfunctionJun 3, 2020Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 289 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ALLEGING INSULIN PUMP FOR UNDER DELIVERING BECAUSE CUSTOMER'S BLOOD GLUCOSE LEVEL WENT DOWN BY INSULIN SHOT. CUSTOMER DECLINED TO CHECK AIR BUBBLES AND LEAK. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10113700 ↗
• InjuryMay 21, 2020Failure to Cycle; Detachment of Device or Device Component; No Apparent Adverse Event; Failure to Cycle; Detachment of Device or Device Component; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER CURRENT BLOOD GLUCOSE LEVEL WAS 523 MG/DL AND THE OTHER BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THE INSULIN SQUIRT OUT DURING MANUAL PRIME. THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH SHOTS FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10078991 ↗
• InjuryMay 21, 2020Failure to Cycle; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Failure to Cycle; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA ALSO INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AND 523 MG/DL AND GAVE HERSELF SELF-ACTING INSULIN. CUSTOMER STATES INSULIN WAS SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STUCK OUT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10078176 ↗
• MalfunctionMay 19, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION INDICATED BY MEDTRONIC THAT THE INSULIN PUMP DISPLAY SCREEN WAS GETTING HARDER TO SEE. 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 10068617 ↗
• MalfunctionMay 13, 2020Device Alarm System; Priming Problem; Device Alarm System; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THEY HAD PROBLEMS WITH THE INSULIN INTO THE PUMP. IT WAS STATED THAT THEY WERE NOT SHOWING NUMBER AND THE INSULIN WAS GOING THROUGH AND THERE WERE NO NUMBERS ON THE PUMP. CUSTOMER STATED THAT THE INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THAT THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE 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 10051391 ↗
• MalfunctionMay 8, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. 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 10040435 ↗
• MalfunctionMay 8, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR. CUSTOMER DID NOT RECALL BLOOD GLUCOSE AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED . THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037683 ↗
• MalfunctionMay 7, 2020Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE MOTOR ERROR ALARMS. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS LOOSE AND PROTRUDED. 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 10031993 ↗
• MalfunctionMay 1, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THERE WAS CRACK ON SCREEN AND HARD TO READ IT. 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 10016544 ↗

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-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-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-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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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