Paradigm® REAL-Time Revel™ MMT-723LNAB (UDI 00613994904522)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994904522), received between Aug 22, 2017 and Jul 3, 2020 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCHES ON SCREEN MARKING IT HARDER TO READ. INSULIN PUMP HAD MOTOR ERROR AND BUTTON ISSUE. 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 10229228 ↗
• MalfunctionApr 13, 2020Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED UNEXPLAINED MOTOR ERRORS, INSULIN PUMP HAD REJECTED BRAND NEW BATTERY AND NO DELIVERY ALARMS WITHOUT EXPLANATION. 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 9952209 ↗
• MalfunctionMar 6, 2020Battery Problem; Moisture or Humidity Problem; Battery Problem; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT SCREEN WAS CLOUDY AND IT HARD TO READ. CUSTOMER STATED THAT BATTERY LIFE WAS DIMINISHED. 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 9796584 ↗
• MalfunctionMar 5, 2020Computer Software Problem; Mechanical Problem; Patient Device Interaction Problem; Computer Software Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS CRACKED AND THE MOTOR KEPT POPPING OUT CAUSING INACCURATE INSULIN DELIVERS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9791802 ↗
• MalfunctionMar 5, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BUTTONS HARDER TO PRESS. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS CRACKS IN CASING, CRACKED AT THE BATTERY THREADING, LOUDER DURING REWIND. 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 9791566 ↗
• MalfunctionFeb 24, 2020Display or Visual Feedback Problem; Battery Problem; Material Integrity Problem; Display or Visual Feedback Problem; Battery Problem; Material Integrity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD PARTIAL DISPLAY. THE CUSTOMER STATED THAT THEY TRIED MULTIPLE BATTERIES BUT ISSUE WAS NOT RESOLVED. CUSTOMER STATED THE INSULIN PUMP WAS NEITHER DROPPED NOR BUMPED. CUSTOMER ALSO STATED SOME CRACKS AND PIECED CHIPPED OFF OF THE TOP OF BATTERY CAP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9743382 ↗
• MalfunctionDec 13, 2019Display or Visual Feedback Problem; Date/Time-Related Software Problem; Display or Visual Feedback Problem; Date/Time-Related Software Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT TWO LINES ON INSULIN PUMP SCREEN WERE NOT WORKING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER REPORTED THAT AFTER CHANGING BATTERY LED TO LOSING OF DATE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465184 ↗
• MalfunctionAug 19, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HIS INSULIN PUMP HAD RECEIVED MOTOR ERROR EVERY TIME HE TRIED TO BOLUS AND ALSO MOTOR POSITION ENCODER ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING. 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 8904641 ↗
• MalfunctionMay 21, 2019Mechanical Problem; Power Problem; No Apparent Adverse Event; Insufficient Device Problem Information; Mechanical Problem; Power Problem; No Apparent Adverse Event; Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAD RECEIVED UNSPECIFIED ALARMS AND MOTOR ERRORS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE CUSTOMER ALSO REPORTED THAT HER INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS AND THE PUMP WAS REJECTING NEW BATTERIES. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8626762 ↗
• MalfunctionFeb 7, 2019No Display/Image; No Display/Image

  THE CUSTOMER WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 353 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WIFE STATED THAT PUMP DOESN'T ALARM LOW BATTERY, IT JUST DRAINS VERY QUICKLY WITHIN 1 DAY AND PUMP HAS SHUT OFF ON IT'S OWN WITH NO WARNING SEVERAL TIMES. THE CUSTOMER WIFE STATED THAT CRACK FOUND ON THE BATTERY COMPARTMENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8314299 ↗
• MalfunctionJan 30, 2019Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN SQUIRTED OUT DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. INSULIN PUMP HAD UNEXPLAINED NO DELIVERY ALARMS AND SMALL PIECE NEAR THE RESERVOIR WAS VERY THIN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8288329 ↗
• MalfunctionSep 24, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND INSULIN WAS SQUIRTING OUT DURING PRIMING PROCESS. THE 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 7901220 ↗
• MalfunctionAug 7, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL BLANK DISPLAY ANOMALY, UNEXPECTED RESTART ALARM, EXTERNAL RAM CRC ERROR ALARM, BATTERY FAILED ALARM AND OFF NO POWER ALARM ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THEY REPLACED THE BATTERY HOWEVER BLANK DISPLAY ANOMALY RECURRED FOR A SECOND TIME. CUSTOMER ADVISED THEY DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALARM. 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 7758127 ↗
• InjuryApr 10, 2018Failure to Deliver; High Test Results; Device Displays Incorrect Message; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 9:25 PM WITH BLOOD GLUCOSE WAS 600 MG/DL. THE CURRENT BLOOD GLUCOSE IS 120 MG/DL. THE INSULIN PUMP RECEIVED BATTERY OUT LIMIT ALARMS AND SELF TEST WAS PERFORMED AND THERE WAS NO ISSUE. THE CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE WITH INSULIN SHOTS. THE CUSTOMER WAS WEARING INSULIN PUMP DURING HOSPITALIZATION. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7413685 ↗
• MalfunctionMar 14, 2018Device Displays Incorrect Message; Infusion or Flow Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT INSULIN WAS "SQUIRTING OUT" DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 7339942 ↗
• MalfunctionJan 5, 2018No Display/Image

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BLANK DISPLAY AND HAD CORRODED SPRING. CUSTOMER¿S BLOOD GLUCOSE WAS 183 MG/DL AT TIME OF INCIDENT. CUSTOMER ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN AS PER HCP¿S INSTRUCTIONS. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170082 ↗
• MalfunctionDec 1, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FORCE SENSOR CALIBRATION VALUES CORRUPTED AND MOTOR ERROR. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE INCIDENT. 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 DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7076788 ↗
• InjuryAug 24, 2017Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 590 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 506 MG/DL AT THE TIME OF CALL. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6816945 ↗
• MalfunctionAug 22, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED FAILED BATTERY TEST. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 169 MG/DL AT THE TIME OF THE INCIDENT. THE ALARM WAS NOT RESOLVED DURING TROUBLESHOOTING. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HCP'S INSTRUCTION. ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6811742 ↗

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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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