Paradigm® REAL-Time Revel™ MMT-523LNAB (UDI 00643169151277)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00643169151277), received between Jun 6, 2017 and Jul 29, 2020 — classified as 25 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (14 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 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER STATED THAT, THE BUTTONS WERE HARD TO PRESS. THE CUSTOMER ALSO STATED THAT, THERE WERE SCRATCH ON THE SCREEN AND HAD RAINBOW EFFECT AND 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 10337549 ↗
• MalfunctionMar 28, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S BUTTON WERE NOT WORKING. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9892569 ↗
• MalfunctionMar 13, 2020Display or Visual Feedback Problem; Mechanical Problem; Display or Visual Feedback Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR 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 9828013 ↗
• MalfunctionFeb 7, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE CUSTOMER HAD TO PRESS BUTTONS HARDER FOR INSULIN PUMP TO RESPOND AND HAD UNEXPLAINED NO 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 9680325 ↗
• MalfunctionDec 31, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND REWINDING DURING BOLUS. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT THE INSULIN PUMP DID NOT EXPOSED TO HIGH MAGNETIC FIELD. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED THAT THE INSULIN PUMP ALARM HISTORY CONTAINS MORE THAN ONE MOTOR ERROR ALARM WITHIN THE LAST 30 DAYS. 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 9534434 ↗
• MalfunctionDec 17, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAS SQUIRTED INSULIN BEFORE PRIMING, RAN OUT OF INSULIN WITHOUT A WARNING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481171 ↗
• MalfunctionDec 4, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS DROP AND CHIPPED AND ALSO PIECE CAME OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR LIP RING WAS DAMAGE. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. THE CUSTOMER REPORTED THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 9414293 ↗
• MalfunctionNov 13, 2019Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem; Device Difficult to Program or Calibrate; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 128 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE BUTTONS WERE UNRESPONSIVE. CUSTOMER ALSO MENTIONED THAT THE INSULIN PUMP COULD HAVE EXPOSED TO SWEAT. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. 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: No Consequences Or Impact To Patient

  MAUDE report 9314371 ↗
• MalfunctionOct 30, 2019Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Material Integrity Problem; Display or Visual Feedback Problem; Obstruction of Flow; Battery Problem; Material Integrity Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SHADOW IN THE SCREEN HAD TO ROLL IT TO SEE THE NUMBER SOMEWHAT ANGLE IT. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND CHANGE ONCE EVERY WEEK. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD FEW NO DELIVERY ERRORS AND BATTERY CAP INDENTATION WAS GETTING WORN OUT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9254097 ↗
• MalfunctionJul 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS OF THE INSULIN PUMP WERE LESS RESPONSIVE. BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8810295 ↗
• MalfunctionJun 20, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS UNABLE TO LOCK INTO PLACE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 80 MG/DL. CUSTOMER STATES THAT THE DAMAGE ON RESERVOIR COMPARTMENT FROM THE INSULIN PUMP. CUSTOMER STATED CRACK ON THE BATTERY COMPARTMENT. 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 8715155 ↗
• MalfunctionJun 20, 2019Connection Problem; Material Integrity Problem; Patient Device Interaction Problem; Connection Problem; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 280 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8715126 ↗
• MalfunctionJun 19, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BOTTOM OF THE INSULIN PUMP COMES OFF AND SHE CAN SEE THE WIRES. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 281 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8711231 ↗
• MalfunctionJun 10, 2019Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BUTTONS NOT WORKING AND THEY WERE STICK. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER ALSO STATED THAT CRACKS ON CASE REJECTED BATTERY. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8681889 ↗
• MalfunctionMay 27, 2019Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RESET ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES THAT THEY DID NOT USE THE CLEAR SETTINGS FEATURE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8643710 ↗
• MalfunctionApr 16, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Material Integrity Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Material Integrity Problem

  THE CUSTOMER'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE HARDER TO PRESS, DARK SPOT ON THE INSULIN PUMP SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ALSO REPORTED THAT THE BATTERY CAP WAS TORN OFF. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517361 ↗
• MalfunctionApr 8, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER STATED THAT THE INSULIN PUMP HAD BUTTON ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THERE WAS CRACK IN LEFT CORNER OF THE INSULIN PUMP, THE BUTTONS WERE HARDER TO PUSH. THE TROUBLESHOOTING WAS DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8490356 ↗
• MalfunctionMar 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE ACT BUTTONS WAS NOT RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE DEVICE WAS NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8411312 ↗
• MalfunctionMar 1, 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 RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS PROTRUDING. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8381219 ↗
• MalfunctionFeb 22, 2019Failure to Cycle; Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Failure to Cycle; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 377 MG/DL. THE CUSTOMER REPORTED THAT THE KEYPAD WAS RESPONDING. CUSTOMER REPORTED THEY WERE NOT ABLE TO CLEAR THE ALARM. CUSTOMER STATED THEY WERE NOT ABLE TO REWIND THE PUMP. CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8360881 ↗
• MalfunctionFeb 12, 2019No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DIED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 89 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS REPORTED THAT THE BATTERY CAP WAS NOT DAMAGED. THE CUSTOMER WAS ADVISED TO REPLACE AND DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8330735 ↗
• MalfunctionDec 13, 2018Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Mechanical Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY AND UNSPECIFIED ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP GRINDS DURING REWIND, MOTOR ERRORS, E AND A CODES AND BUTTONS WERE STICKING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8159166 ↗
• InjuryNov 26, 2018No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS AT 392 MG/DL THE TIME OF INCIDENT. CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVEL WITH MANUAL INJECTION. CUSTOMER DID NOT REPORT ANY SYMPTOMS RELATED TO THE HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8104392 ↗
• MalfunctionNov 22, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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: No Consequences Or Impact To Patient

  MAUDE report 8098714 ↗
• InjuryNov 20, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP FAILED SEVERAL TIMES SINCE (B)(6) 2018 WITH BLOOD GLUCOSE OF 49 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE FOR THE LOW. THE CALLER DID NOT MENTION HOW THE CUSTOMER WAS TREATED. THE CALLER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENTS BUT HAD TAKEN IT OFF AT SOME POINT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CALLER DECLINED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8092891 ↗

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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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