Paradigm® REAL-Time Revel™ MMT-723LNAP (UDI 00613994904492)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994904492), received between Jun 6, 2017 and Jul 20, 2020 — classified as 5 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2020Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Battery Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCRATCHES ON THE INSULIN PUMP DISPLAY, RAINBOW EFFECT MAKING IT HARD TO READ, HAD TO REWIND MORE THAN ONCE AND REWIND WAS SLOWER, HAD AN UNEXPLAINED AND RANDOM NO DELIVERY ALARM AND INSULIN PUMP REJECTED SOME NEW BATTERIES. 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 10300073 ↗
• InjuryJun 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL AT THE TIME OF INCIDENT AND OTHER RELEVANT BLOOD GLUCOSE LEVEL WAS 300 MG/DL TO 400 MG/DL. CUSTOMER EXPERIENCED NAUSEA, ABDOMINAL PAIN, DRY HEAVING AND THIRSTY. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED EVENT. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER DID ALLEGE THAT THE INSULIN PUMP WAS UNDER DELIVERING BECAUSE CUSTOMER WHILE DISCONNECTED RAN UNIT AND SAW NOTHING CAME. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Abdominal Pain; Hyperglycemia; Nausea; Vomiting

  MAUDE report 10118027 ↗
• InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE OVER 8 YEARS AGO WHILE ON A MEDTRONIC PUMP, WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THEY WERE PREGNANT AT THE TIME OF THE EVENT AND PUMP FAILURE LED TO THE LOW. THE CUSTOMER DID NOT MENTION HOW THEY WERE TREATED. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THIS WAS A PAST EVENT AND THE CUSTOMER HAD STOPPED USING THE PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Loss of consciousness

  MAUDE report 9691636 ↗
• InjuryJun 4, 2019Device Alarm System; Failure to Cycle; No Apparent Adverse Event; Priming Problem; Device Alarm System; Failure to Cycle; No Apparent Adverse Event; Priming Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 439 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THEY DID HEAR THE SECOND SERIES OF BEEPS WHEN THEY WENT THROUGH THE REWIND PRIME PROCESS. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND TO REVERT TO THE BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8667303 ↗
• MalfunctionMar 22, 2019Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPRISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 340 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER WAS ABLE TO COMPLETE REWIND INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8443256 ↗
• MalfunctionMar 11, 2019Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED TWO MOTOR ERROR ALARMS AS WELL AS NO DELIVERY ALARM DURING MANUAL PRIME. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN DID NOT EXIT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER STATES INSULIN EXITED THE TUBING. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO RETRIEVE AND SAVE INSULIN PUMP SETTINGS AND TO REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407463 ↗
• MalfunctionSep 20, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS GIVING BATTERY OUT LIMIT ALARMS. INSULIN PUMP HAD BEEN DROPPED AND DAMAGED MULTIPLE TIMES. BLOOD GLUCOSE LEVEL WAS 81 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING DID NOT RESOLVE ISSUE. PRODUCT WILL RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7892458 ↗
• MalfunctionSep 17, 2018Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE BLANK DISPLAY AS WELL AS CONTINUOUS NOISE. INSULIN PUMP WAS EXPOSED TO MOISTURE.THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882744 ↗
• MalfunctionAug 3, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A DAMAGED AND ALSO RECEIVED BLANK DISPLAY. THE BLOOD GLUCOSE LEVEL WAS 204 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS CRACKED. THE PRODUCT WILL RETURN FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7746893 ↗
• MalfunctionJun 11, 2018Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE BUTTONS WERE UNRESPONSIVE. 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: No Consequences Or Impact To Patient

  MAUDE report 7589462 ↗
• MalfunctionJun 6, 2018Failure to Deliver

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED INSULIN NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER ALSO STATED THAT THE EVENT WAS NOT RESOLVED BY INFUSION SET, RESERVOIR OR COMPLETE SET CHANGE .TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7575720 ↗
• MalfunctionFeb 20, 2018Device Displays Incorrect Message

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2018 BLOOD GLUCOSE OF OVER 600 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS PAIN, THIRST AND FREQUENT TRIP TO THE BATHROOM. THE CUSTOMER'S BLOOD GLUCOSE READING WENT DOWN TO 595 MG/DL AFTER TREATMENT WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE READING WENT BACK UP A FEW MINUTES AFTER AND WAS TAKEN TO THE HOSPITAL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. CUSTOMER'S PARENT DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER¿S PARENT ALSO REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER¿S PARENT STATED THAT THE INSULIN PUMP ACT BUTTON WAS HARD TO PUSH. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND UNABLE TO CONFIRM IF THE TIME IS ADVANCING. THE CUSTOMER¿S PARENT WAS ADVISED TO HAVE THE CUSTOMER DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7282972 ↗
• MalfunctionFeb 16, 2018No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 167 MG/DL. THE CUSTOMER STATES SHE REPLACED BATTERIES OVER 8 TIMES AND THE PUMP WAS COMPLETELY DEAD AND NOT RESPONDING. 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 7277209 ↗
• InjuryFeb 14, 2018No Display/Image; Device Inoperable; Structural Problem

  CUSTOMER REPORTED VIA PHONE CALL FOR BLANK DISPLAY AND COSMETIC DAMAGE. BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS UNKNOWN. CUSTOMER REPORTED BLANK DISPLAY AND MENTIONED THAT INSULIN PUMP WAS NOT WORKING. THE CUSTOMER REPORTED CRACKED PIECES AROUND THE BATTERY COMPARTMENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7271834 ↗
• MalfunctionSep 21, 2017Device Displays Incorrect Message; No Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THE INSULIN DID NOT EXIT AND PUMP ALARMED NO DELIVERY DURING PRIMING. THE CUSTOMER WAS ADVISED THAT THE PUMP NEEDS TO BE REPLACED. THE CUSTOMER WAS ALSO ADVISED TO RETRIEVE AND SAVE PUMP SETTINGS AND ADVISED TO REVERT TO BACKUP PLAN PER HEALTHCARE PROFESSIONAL RECOMMENDATION. THE PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6882918 ↗
• InjuryAug 25, 2017Device Operates Differently Than Expected

  THE CUSTOMER¿S NURSE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WOULD NOT LOAD AND HAD ALARMED A COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL DURING THE INCIDENT WAS 370 MG/DL. THE CUSTOMER WAS AT THE HOSPITAL. THEY WERE HOSPITALIZED ON (B)(6) 2017 AT 12:40 A.M. DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS 502 MG/DL. THE CUSTOMER WAS HAVING TROUBLE WITH THE DEVICE AND HAD RESET IT. THE CUSTOMER HAD SYMPTOMS SUCH AS NAUSEA, CHEST PRESSURE, DRY MOUTH, AND FREQUENT URINATION. THEY WERE TREATED WITH INTRAVENOUS THERAPY AND MANUAL INJECTION. THE CUSTOMER WAS NOT WEARING THE DEVICE AT THE TIME OF HOSPITALIZATION. THEY WERE OFF THE DEVICE FOR LESS THAN 48 HOURS PRIOR TO THE HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED FOR THE COMPROMISED FORCE SENSOR SYSTEM. THE DEVICE WILL BE REPLACED AND RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6820027 ↗
• MalfunctionJun 6, 2017Device Operates Differently Than Expected; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A PROTRUDED DRIVE SUPPORT CAP. THE CUSTOMER COULD READ THE INSULIN PUMP'S SCREEN BUT IT WAS NOT FUNCTIONING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6614566 ↗

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