Paradigm® REAL-Time Revel™ MMT-523LNAB (UDI 00643169932944)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00643169932944), received between Jan 5, 2018 and Jun 9, 2020 — classified as 33 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (7 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RETAINER RING OF INSULIN PUMP WAS BROKEN. THE CUSTOMER STATED THAT THE RESERVOIR LOCKED INTO PLACE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10131974 ↗
• MalfunctionFeb 17, 2020Display or Visual Feedback Problem; Display or Visual Feedback Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COLORED CIRCLE ON SCREEN. CUSTOMER DID NOT WANT TO TROUBLESHOOT AT THAT TIME. 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 9718685 ↗
• MalfunctionFeb 5, 2020Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Obstruction of Flow; Power Problem; Insufficient Device Problem Information

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HADE CODE ERROR. CUSTOMER STATED THAT THE INSULIN PUMP HAD REJECTED BRAND NEW BATTERY. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALERTS. 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 9674811 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER¿S PARTNER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED FOR 3 HOURS DUE TO HYPERGLYCEMIA AT 2.30PM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER STATED THEY HAD BLOCKAGE IN THE HEART, WHICH RESULTS IN HIS BLOOD GLUCOSE GETTING HIGH. CUSTOMER STATED THAT THE METER HAD BEEN READING 465 MG/DL, BUT WHEN THE HOSPITAL TESTED IT READ 400 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP AND DECLINED TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9621068 ↗
• MalfunctionSep 30, 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 SOMETIMES HAD TO BE PRESSED HARDER OR MULTIPLE TIMES TO GET THE INSULIN PUMP TO WORK. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9133117 ↗
• MalfunctionAug 14, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 131 MG/DL. THE CUSTOMER STATES THEY HAVE TRIED ALL REMEDIES. THE CUSTOMER DECLINED TO CONTINUE TROUBLESHOOTING. CUSTOMER STATES THE TUBING WAS NOT BENT OR KINKED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8891765 ↗
• InjuryJul 22, 2019Detachment of Device or Device Component; Patient Device Interaction Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND DRIVE SUPPORT CAP WAS FLUSHED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. OTHER RELEVANT BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 448 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTIONS FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8810347 ↗
• InjuryJul 17, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 424 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM WHICH WAS RESOLVED BY COMPLETE SET CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8797682 ↗
• MalfunctionJul 17, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP BUTTONS WERE DIFFICULT TO PRESS SOMETIMES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT INSULIN PUMP HAD NO DELIVERY ALARMS AND PURPLE DISCOLORATION WHERE CANNULA CONNECTS TO THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797384 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 600 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THAT CANNULA WAS BENT. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8756494 ↗
• MalfunctionJun 19, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD CIRCLE ON THE PUMP. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 164 MG/DL. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8711548 ↗
• MalfunctionJun 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8706716 ↗
• MalfunctionJun 3, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED MOTOR ERROR ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8661571 ↗
• MalfunctionMay 23, 2019Device Alarm System; Failure of Device to Self-Test; Device Alarm System; Failure of Device to Self-Test

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ABSENCE OF ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 201 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST. THE CUSTOMER REPORTED THAT THE INSULIN WAS DRIPPING AND DID NOT ALARM NO DELIVERY UNTIL 5U. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8635181 ↗
• MalfunctionMay 23, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER'S FAMILY REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE INSULIN PUMP BUTTONS WERE HARD TO PRESS. THE CUSTOMER REPORTED THAT THE TIME CLOCK ADVANCED FOR ONE MINUTE. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635160 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY CONTACTED THE HEALTH CARE PROFESSIONAL REGARDING HIGH BLOOD GLUCOSE LEVEL EVENT. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE 383 MG/DL, 770 MG/DL AND 440 MG/DL. THE CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER REPORTED THAT THEY TREATED HIGH BLOOD GLUCOSE LEVEL WITH THE MANUAL INJECTIONS AND INSULIN PUMP. THE CUSTOMER REPORTED THAT THEY DID NOT EXPERIENCE ANY SYMPTOM RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER ALLEGED THE INSULIN PUMP FOR UNDER DELIVERY BECAUSE SHE KEPT TREATING AND IT WAS NOT GOING REALLY DOWN AND EVEN CHANGE OUT THE SET. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL. THEY REPORTED THAT THE INSULIN PUMP PASSED THE HIGH PRESSURE TEST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8618922 ↗
• MalfunctionMay 10, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 185 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT WHILE CHANGING THE SET, THE INSULIN PUMP STOPPED WORKING AND HAD A MOTOR ERROR ALARM. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL OR SLIGHTLY INDENTED. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. 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 8598649 ↗
• MalfunctionMay 7, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT DELIVERING ANYMORE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585047 ↗
• MalfunctionApr 24, 2019Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 400 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATES INSULIN PUMP HAD MOTOR ERROR. CUSTOMER DID NOT REPORT MOTOR POSITION ENCODER ERROR. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8542974 ↗
• MalfunctionApr 23, 2019Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE HARD TO PRESS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATE THAT TIME MOVE FORWARD. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8539000 ↗
• MalfunctionApr 19, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AS WELL AS MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 151 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELD. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8530398 ↗
• MalfunctionApr 17, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP'S SCREEN WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE WAS 82 MG/DL. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8525641 ↗
• MalfunctionMar 29, 2019Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE RF PIC FAILED SELF TEST. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463508 ↗
• InjuryMar 15, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED BUT NOT RELATED TO DIABETES AND RESERVOIR CAP WAS MESSED UP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATE THAT WAS NOT ABLE TO LOCK IN PLACE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423974 ↗
• MalfunctionMar 5, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8389800 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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