Paradigm® REAL-Time Revel™ MMT-523NAS (UDI 00643169077683)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00643169077683), received between Jun 7, 2017 and Jul 7, 2020 — classified as 7 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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 40 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SOMETIMES THE BUTTONS DID NOT SELECT WHEN PRESSED AND HAD ISSUES WITH THE BATTERY. 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 10238266 ↗
• MalfunctionApr 13, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST, KEYPAD ANOMALY AND NO DELIVERY ALARM ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. 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 9952804 ↗
• MalfunctionMar 24, 2020Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CHIPPED NEAR BATTERY CAP AND CRACKED DOWN SIDE TO DISPLAY. THE CUSTOMER STATED INSULIN PUMP HAD REJECTED NEW BATTERY, SCRATCHES AND RAINBOW ON SCREEN WITH UNEXPLAINED NO DELIVERY AND LOUDER REWIND. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9870770 ↗
• MalfunctionJan 3, 2020No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DIED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER DECLINED TO TROUBLESHOOTING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9544742 ↗
• MalfunctionDec 31, 2019No Display/Image; Battery Problem; Power Problem; No Display/Image; Battery Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 171 MG/DL, 69 MG/DL AND TODAY IT WAS 67 MG/DL. CUSTOMER REPORTED THAT THEY RECEIVED FAILED BATTERY TEST ALARM AND BATTERY OUT LIMIT ALARM AS WELL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR FAILED BATTERY TEST. CUSTOMER WOKE UP THIS MORNING INSULIN PUMP WAS BEEPING 6 TIMES AND IT WAS DEAD. CUSTOMER STATED THEY DID NOT RECEIVED A REQUEST TO REWIND INSULIN PUMP. CUSTOMER STATED THAT THE ISSUE STARTED WITHIN THE LAST WEEK IT WENT DEAD ONE DAY LAST WEEK, SO THEY REPLACED THE BATTERY. CUSTOMER REPORTED THIS WEEK HE HAD PUT SEVERAL DIFFERENT BATTERIES IN AND IT WAS STILL GAVE HIM MESSAGES THAT THE BATTERY WAS NOT SUFFICIENT AND THEY WERE NEW BATTERIES. CUSTOMER WAS EXPLAINED THAT THE BATTERY OUT LIMIT ALARM DURING NORMAL USE MAY INDICATE A LOOSE BATTERY CAP. CUSTOMER WAS ADVISED THAT WILL SEND A REPLACEMENT BATTERY CAP AND ADVISED TO MONITOR INSULIN PUMP. CUSTOMER WAS ADVISED THAT IF THE BATTERY CAP REPLACED DID NOT RESOLVE THE ISSUE HE WILL NEED TO GO THROUGH UPGRADE INSULIN PUMP. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9535082 ↗
• MalfunctionDec 11, 2019Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY WERE UNABLE TO CLEAR THE ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449419 ↗
• MalfunctionDec 11, 2019Device Difficult to Program or Calibrate; Use of Device Problem; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED RANDOM NO DELIVERY AND REJECTED NEW BATTERIES, INSULIN PUMP HAD CRACK ON THE BATTERY CASE AND HAD LOST SETTINGS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9449380 ↗
• MalfunctionNov 28, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WAS UNRESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 228 MG/DL. CUSTOMER OBSERVE TIME CLOCK FOR ONE MINUTE AND TIME WAS ADVANCES. CUSTOMER WAS ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9388136 ↗
• MalfunctionAug 6, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE NOT RESPONDING. CUSTOMER¿S BLOOD GLUCOSE WAS 60 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE TIME WAS ADVANCING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8863706 ↗
• MalfunctionApr 23, 2019Use of Device Problem; Battery Problem; Power Problem; Priming Problem; Use of Device Problem; Battery Problem; Power Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY HAD INSULIN SQUIRTING OUT DURING PRIMING, A OR E ALARMS, FALSE AND UNEXPLAINED NO DELIVERY ALARMS, PUMP HAS REJECTED NEW BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8538540 ↗
• MalfunctionApr 3, 2019Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTS DURING THE PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED CRACK ON THE BATTERY CAP INDENTATION ALSO INSULIN PUMP REJECT THE NEW BATTERIES. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARM. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8476941 ↗
• MalfunctionMar 28, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN SQUIRTING DURING THE PRIMING AND THE SLOWER DURING THE REWIND. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT BUTTONS WERE LESS RESPONSIVE AND INSULIN PUMP HAD NO DELIVERY ALARM. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462652 ↗
• MalfunctionMar 14, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THE INSULIN PUMP HAD CRACK OR CHIP WHERE THE BATTERY CAP GOES, NOT SURE IT WAS HOLD UP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8419776 ↗
• MalfunctionFeb 25, 2019No Display/Image; Power Problem; No Display/Image; Power Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8365539 ↗
• MalfunctionFeb 15, 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 PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 98MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ALSO STATED THAT DRIVE SUPPORT CAP WAS STICKING OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8342410 ↗
• MalfunctionJan 31, 2019Adverse Event Without Identified Device or Use Problem; Power Problem; Adverse Event Without Identified Device or Use Problem; Power Problem

  NURSE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT WORKING RIGHT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292243 ↗
• MalfunctionJan 31, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE THREADS THAT HOLD THE RESERVOIR IN PLACE WAS BROKEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8291928 ↗
• InjuryDec 11, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 501 MG/DL. THE INSULIN PUMP ALSO HAD BUTTON ERROR. THE CUSTOMER STATED THAT THE BUTTONS OF THE INSULIN PUMP WERE NOT RESPONDING. 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. TROUBLESHOOTING WAS NOT PERFORMED FOR HIGH BLOOD GLUCOSE. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8150222 ↗
• InjuryNov 17, 2018Adverse 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 HIGH BLOOD GLUCOSE LEVELS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 950 MG/DL. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE LEVELS VIA INSULIN PUMP. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVELS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8082233 ↗
• MalfunctionAug 29, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE ACT KEY WAS NOR RESPONDING. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7827900 ↗
• MalfunctionAug 17, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY, NO DELIVERY ALARMS AND COSMETIC DAMAGE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAS FREQUENT NO DELIVERY ALARMS BECAUSE THE RESERVOIR COMPARTMENT WHERE RESERVOIR LOCKS IN IS BROKEN. 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: Hyperglycemia

  MAUDE report 7794317 ↗
• MalfunctionAug 5, 2018Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. IT WAS ALSO MENTIONED THAT THE DRIVE SUPPORT CAP WAS LOOSE. BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750146 ↗
• MalfunctionJul 18, 2018No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. BLOOD GLUCOSE WAS 295 MG/DL AT TIME OF INCIDENT. TROUBLESHOOTING WAS COMPLETED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE CUSTOMER WILL RECEIVE A REPLACEMENT INSULIN PUMP AND WILL RETURN THE ONE THEY CURRENTLY USE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7701349 ↗
• MalfunctionJun 14, 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. CUSTOMER 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 7600311 ↗
• MalfunctionMay 10, 2018Vibration; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE AND VIBRATING WITHOUT AN ALARM OR ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7502092 ↗

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