Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00643169077676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169077676), received between Jun 2, 2017 and Dec 23, 2019 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2019Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON THAT WERE STICKY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER RECEIVED NO DELIVERY ALARMS AND THE BATTERY LIFE WAS AWFUL. THE CUSTOMER EVEN HAD TROUBLE LOADING NEW INSULIN BECAUSE THE BUTTONS WOULD NOT WANT TO WORK, SO THEY HAD TO TAKE THE BATTERY OUT AND RESTART THE WHOLE THING JUST TO CHANGE SETS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9509261 ↗
• MalfunctionNov 8, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THE BUTTONS HAD TO PRESS LITTLE BIT HARDER, THE INSULIN PUMP HAD ERROR CODE BEFORE AND INSULIN SHOOT OUT OF INFUSION SET WHEN PRIMING INSTEAD OF DRIPPING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE BATTERY CAP HAD A BUNCH OF CHIPS AND DINGS, MINOR SCRAPES ON DISPLAY SCREEN AND HAD TO TAKE BATTERY OUT AND RESTART EVERYTHING. THE INSULIN PUMP HAD NO DELIVERY ALARMS A LOT MORE FREQUENTLY IN THE PAST COUPLE MONTHS AND HAD TO REWIND MORE THAN ONCE PER PRIME BECAUSE OF NO DELIVERY ALARMS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9294704 ↗
• MalfunctionNov 12, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT LIP AND THE RIM OF RESERVOIR WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 176 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8058814 ↗
• MalfunctionOct 31, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR AND MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM. THE CUSTOMER REPORTED THAT THEY HAD RECEIVED MOTOR POSITION ENCODER ERROR. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8023839 ↗
• MalfunctionOct 18, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCED SYSTEM AND NO DELIVERY ALARM. 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 7976965 ↗
• InjuryJun 4, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY AND HAD AN UNEXPECTED RESTART ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 274 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART ALARM AND WOULD NOT TURN ON. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED 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: Hyperglycemia

  MAUDE report 7567845 ↗
• MalfunctionMay 15, 2018No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. 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 7513492 ↗
• MalfunctionDec 26, 2017No Display/Image; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A FAILED BATTERY ALARM AND BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED GETTING FAILED BATTERY ALERT AND THEN AT TIMES BLANK SCREEN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOT FOR FAILED BATTERY TEST AND THE CUSTOMER STATED THAT SCREEN WAS BLANK AND CUSTOMER DID NOT RECEIVE FAILED BATTERY TEST. THE CUSTOMER WAS ALSO ASSISTED WITH TROUBLESHOOT FOR BLANK DISPLAY. CUSTOMER STATES THE CONTACTS ON THE BATTERY CAP ARE NOT MISSING OR DAMAGED. CUSTOMER STATES BATTERY COMPARTMENT IS NEITHER DAMAGED NOR CORRODED. CUSTOMER STATES THE SPRING IS NEITHER DAMAGED NOR CORRODED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN PER HEALTHCARE PROFESSIONAL'S INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7145538 ↗
• InjuryOct 17, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD ISSUES WITH THE TRANSMITTER AND ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. THE CUSTOMER TREATED WITH INJECTION SHOT. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6954800 ↗
• MalfunctionOct 16, 2017Excess Flow or Over-Infusion; Device Displays Incorrect Message; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS OVER DELIVERING INSULIN AND FAILED BATTERY ALARM. THE CUSTOMER STATED INSULIN WAS LEAKING COMING OUT OF SET TO FAST. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE AND THE BLOOD GLUCOSE VALUE AT THE TIME OF THE INCIDENT WAS 94 MG/DL. THE CUSTOMER STATED THAT THE CUSTOMER WAS NOT CONNECTED TO THE PUMP WHILE PERFORMING TROUBLESHOOT RELEVANT TO REPORT THAT THE PUMP WAS OVER-DELIVERING. THE CUSTOMER REVIEWED ALARM HISTORY AND HAD FOUND A BAD BATTERY ALARM OR FAILED BATTERY. THE CUSTOMER CHECKED THE ALARM HISTORY AND HAD A LOW BATTERY WARNING LOW BATTERY. THE CUSTOMER ADVISED THAT THE RECHARGEABLE BATTERIES SHOULD NOT BE USED AS THEY HAVE LOW VOLTAGE AND DEGRADE OVER TIME. THE CUSTOMER WAS ADVISED TO MONITOR THE PUMP AND CALL IF PROBLEMS RECURS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6951761 ↗
• MalfunctionSep 26, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER WAS ABLE TO REWIND THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS COMING OUT WHEN THEY WERE PERFORMING THE REWIND. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6894397 ↗
• InjuryJun 28, 2017Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY WOKE UP WITH A HIGH BLOOD GLUCOSE LEVEL OF 431 MG/DL. THE CUSTOMER CHANGED THE ENTIRE SET AND TREATED WITH THE INSULIN PUMP. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE READINGS. IT WAS EXPLAINED TO CUSTOMER THE DIFFERENT TYPES OF INFUSION SET AND SITE ISSUES . THE CUSTOMER WAS ADVISE TO SPEAK TO THEIR HEALTHCARE PROVIDER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6673052 ↗
• InjuryJun 27, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED NO DELIVERY, UNEXPECTED RESTART, MEMORY CORRUPTION, AND MOTOR ERROR. THE CUSTOMER WAS ASSISTED WITH MOTOR ERROR TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 375MG/DL AT THE TIME OF THE CALL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER WAS ASSISTED IN CLEARING THE ALARM AND THE INSULIN PUMP WAS ABLE TO COMPLETE REWIND. THE CUSTOMER REPORTED A HIGH BLOOD GLUCOSE LEVEL OF 513MG/DL DURING THE NO DELIVERY AND MOTOR ERROR. THE CUSTOMER TREATED WITH MANUAL INJECTION AND INSULIN PUMP. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE OTHER ALARMS. 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: Hyperglycemia

  MAUDE report 6670382 ↗
• InjuryJun 13, 2017Crack; Moisture Damage

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE READINGS OF 439 MG/DL DUE TO TREATING WITH CARBS FOR A LOW BLOOD GLUCOSE READING OF 51 MG/DL. CUSTOMER HAS TREATED THE HIGH BLOOD GLUCOSE READINGS WITH THE INSULIN PUMP. CUSTOMER MENTIONED THAT THE BUTTON PART OF THE INSULIN PUMP WAS CRACKED AND COMING OFF. CUSTOMER MENTIONED THAT HE WENT SWIMMING WITH THE INSULIN PUMP AND THE DEVICE HAS BEEN EXPOSED TO MOISTURE. IT WAS NOTED THAT THE CUSTOMER LANDED ON THE INSULIN PUMP WHEN HE GOT IN THE POOL AND THE FLUID WAS NOTICEABLE UNDER THE LCD WINDOW. CUSTOMER ALSO MENTIONED HAVING ISSUES WITH THE KEYPAD. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK UP PLAN. INSULIN PUMP IS BEING RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6638994 ↗
• InjuryJun 5, 2017Bent; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WOKE UP TO A HIGH BLOOD GLUCOSE LEVEL OF 510 MG/DL. THE CUSTOMER STATED THE INFUSION SET¿S NEEDLE WAS BENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 489 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT THEY ATE AND THEIR BLOOD GLUCOSE LEVEL WAS STARTING TO GO UP. THE NEW INFUSION SET WAS ALSO GIVING HER A NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED AND INSULIN EXITED WITHOUT INCIDENT. THE CANNULA WAS NOT BENT. THE INFUSION SETS WILL BE REPLACED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6613056 ↗
• InjuryJun 2, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 40 MG/DL. CUSTOMER STATED MIGHT HAVE OVER BOLUSED FOR BREAKFAST. BY LUNCH TIME CUSTOMER WAS DISORIENTED AND CUSTOMER'S NEIGHBOR CALLED EMERGENCY MEDICAL SERVICES. THE CUSTOMER WAS TREATED WITH GLUCOSE TABS AND FOOD, BLOOD GLUCOSE WENT UP TO 280 MG/DL. TREATED HIGH WITH INSULIN PUMP. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6610087 ↗

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