Paradigm® REAL-Time Revel™ MMT-723LNAH (UDI 00643169478572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00643169478572), received between Jun 6, 2017 and Feb 4, 2020 — classified as 14 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2020Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER STATED INSULIN PUMP NOT GETTING A MESSAGE WHEN THE INSULIN PUMP WAS OUT OF INSULIN. CUSTOMER PERFORMED DISPLACEMENT TEST AND IT WAS PASSED. CUSTOMER STATED THEY RAN SELF-TEST AND PASSED BUT INSULIN PUMP WAS NOT MAKE ANY AUDIO BEEP AND BEEP SHORT. CUSTOMER DECLINED TROUBLESHOOTING. 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 9663555 ↗
• MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ISSUE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. 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 9362146 ↗
• MalfunctionJul 17, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON NOT WORKING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 210 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THAT THERE WAS NO ALARMS OCCURRED DURING, OR AFTER THE BUTTONS STOPPED 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE DEVICE WILL RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797151 ↗
• MalfunctionJun 4, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY INSULIN PUMP HAD MOTOR ERROR. 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 8665454 ↗
• InjuryApr 12, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED BECAUSE SHE WAS NOT GETTING ENOUGH INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE RESERVOIR HAD LEAK AT THE 2ND PAST O RING. THE CUSTOMER WAS REPORTED THAT THE KEYPAD WAS NOT RESPONDING, SCREEN WENT RAINBOW AND DARK IN PLACES. CUSTOMER ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO REPLACE 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 8507856 ↗
• MalfunctionApr 5, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE CUSTOMER REPORTED THAT THE ACT AND UP ARROW KEY WAS STUCK DURING BOLUS. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8486861 ↗
• MalfunctionNov 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE DRIVE SUPPORT CAP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 103 MG/DL. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS FLUSH. THE 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 BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063157 ↗
• InjurySep 17, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. CUSTOMER ALSO REPORTED THAT INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. 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 7879971 ↗
• MalfunctionAug 29, 2018Device Alarm System; Device Alarm System

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED WITH OFF NO POWER. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 227 MG/DL. TROUBLESHOOTING WAS INITIATED FOR THE OFF NO POWER ALARM. THE CUSTOMER DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. THE BATTERY WAS NOT PREVIOUSLY USED. THE INSULIN PUMP WAS DROPPED. THERE WERE NO UNATTENDED ALARMS. THE BATTERY CAP ALSO HAD WEAR AND TEAR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7829989 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD AN UNDER-DELIVERY ANOMALY. BLOOD GLUCOSE VALUE WAS 438 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS NOT HOSPITALIZED AND DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING THE HIGH BLOOD GLUCOSE VALUE. TROUBLESHOOTING WAS PERFORMED AND THE DEVICE WILL BE REPLACED AND RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 7815453 ↗
• MalfunctionAug 23, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD POSSIBLE OVER DELIVERY. CUSTOMER DID NOT RECALL BLOOD GLUCOSE AT THE TIME OF INCIDENT. TROUBLESHOOT WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7808337 ↗
• MalfunctionAug 1, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7738170 ↗
• InjuryJul 28, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 426MG/DL. THE CUSTOMER TREATED WITH BOLUS. CUSTOMER¿S CURRENT BLOOD GLUCOSE VALUE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED FOR NO DELIVERY. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7729451 ↗
• InjuryJul 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF MG/DL 32 MG/DL. CUSTOMER FEEL OK TO TROUBLESHOOT. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BG EVENT. DRIVE SUPPORT WAS NOT MENTIONED. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF INCIDENT WAS 32 MG/DL. CURRENT BLOOD GLUCOSE READING IS 143 MG/DL. CUSTOMER LOW BLOOD GLUCOSE READING WAS TREATED WITH FOOD. CUSTOMER DIVE SUPPORT WAS NORMAL. CUSTOMER CHANGED THEIR SET ON (B)(6) 2018. CUSTOMER WAS ADVISED TO CALL THEIR HEALTHCARE PROVIDER. THE PRODUCT WAS NOT RETURNED.

  Patient problems: Hypoglycemia

  MAUDE report 7705018 ↗
• InjuryApr 30, 2018Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER HAD SYMPTOMS OF THEIR BLOOD GLUCOSE LEVELS SUCH AS NAUSEOUS. THE CUSTOMER TREATED WITH BOLUS. CUSTOMER'S CURRENT BLOOD GLUCOSE VALUE WAS 347 MG/DL AND THE BLOOD GLUCOSE WAS 404 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER HAD WENT TO URGENT CARE ON (B)(6) 2018 AT ABOUT 2 PM. THE BLOOD GLUCOSE VALUE WHEN ADMITTED TO HOSPITAL WAS 380 MG/DL. THE CUSTOMER COMPLAINED ABOUT HYPERGLYCEMIA AND VAGINAL OR EAR INFECTION. THE CUSTOMER WEARING THE PUMP AT TIME OF HOSPITALIZATION. DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER REPORTS INSULIN EXITED AT THE QR. THERE WERE NO LEAKS OR AIR BUBBLES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7472780 ↗
• MalfunctionApr 18, 2018Break; Crack

  CUSTOMER REPORTED VIA PHONE CALL FOR COSMETIC DAMAGE. BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS TAPED TOGETHER. CUSTOMER REPORTED THAT HER BATTERY CAP WAS BROKEN AND THERE ARE CRACKS ABOVE THE SCREEN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7441175 ↗
• MalfunctionMar 9, 2018Crack

  IT WAS REPORTED THAT THE INSULIN PUMP GOT DAMAGED. THE CUSTOMER STATED THAT CRACK AT BATTERY COMPARTMENT. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7329229 ↗
• MalfunctionMar 7, 2018Crack; No Display/Image

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD BLANK DISPLAY. THE PATIENT¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THERE WAS A CRACK ALONG THE BATTERY SIDE. TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7319825 ↗
• InjuryJan 24, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 405 MG/DL. THE CUSTOMER NEEDED ASSISTANCE WITH PROGRAMMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7216177 ↗
• MalfunctionJan 12, 2018Device Operates Differently Than Expected

  CUSTOMER REPORTED THAT THE RESERVOIR WAS DAMAGED AND THE O-RING WAS COMING OUT. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROFESSIONAL¿S INSTRUCTION. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT PUMP WILL BE SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7187007 ↗
• MalfunctionDec 28, 2017No Display/Image; Device Displays Incorrect Message; Battery Problem; Failure of Device to Self-Test; Inappropriate or Unexpected Reset

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART, FAILED BATTERY TEST ALARM AND BLANK DISPLAY. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 237MG/DL. FAILED BATTERY TEST ALARM WAS RESOLVED. CUSTOMER STATED THE PUMP ALARMED UNEXPECTED RESTART AFTER BATTERY CHANGE. PUMP WAS NOT ALARMING AT TIME OF CALL INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7150939 ↗
• MalfunctionDec 26, 2017Break; Positioning Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR COMPARTMENT WAS DAMAGE AND THE RESERVOIR WAS NOT LOCKING IN PLACE ANYMORE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7146557 ↗
• MalfunctionDec 4, 2017Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS UNDER DELIVERING. THEY ALSO EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 323 MG/DL. THE CUSTOMER¿S CURRENT HIGH BLOOD GLUCOSE 223 MG/DL. CUSTOMER ALLEGED INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER HAD TREATED WITH INSULIN PUMP. THE DRIVE SUPPORT CAP WAS NORMAL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7079605 ↗
• InjuryNov 17, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THAT THEY RECEIVED NO DELIVERY ALARM AND HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 548 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7041400 ↗
• MalfunctionSep 20, 2017No Display/Image; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILURE OF FLASH MEMORY AND NEW SOFTWARE RELEASE DETECTED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 142 MG/DL AT THE TIME OF THE INCIDENT. ALARM DID NOT OCCUR DURING THE REWIND/PRIME SEQUENCE, HOWEVER THE SELF-TEST WAS FAILED AS THE SCREEN WAS NOT ABLE TO NAVIGATE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED 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 6878969 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-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