Paradigm® REAL-Time Revel™ MMT-723RNAB (UDI 00613994748713)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994748713), received between Jul 12, 2017 and Jul 31, 2020 — classified as 7 injuries, 7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2020No Display/Image; Mechanical Problem; Power Problem; Patient Device Interaction Problem; No Display/Image; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS BROKEN AND WAS NO LONGER WORKING, ALSO HAD MOTOR ERROR ALARMS. ALSO REPORTED RANDOM UNEXPLAINED NO DELIVERY ALARMS, HAD REJECTED NEW BATTERIES, RESERVOIR PORT WAS CRACKED AND A PIECE WAS BROKEN OFF ON BATTERY PORT CRACK ON BACK OF PISTON. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10349425 ↗
• MalfunctionJul 29, 2020No Display/Image; No Display/Image

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AND STOPPED WORKING A MONTH AGO. 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 10337025 ↗
• MalfunctionJan 14, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP BUTTONS HAVE TO BE PRESSED MULTIPLE TIMES AND WAS STICKING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT BATTERY CAP HAD MISSING PIECES AND FREQUENTLY NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9585262 ↗
• MalfunctionJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD LOWS ON AND OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSOTMER DELINED TROUBLESHOOT FOR HIGH AND LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8706856 ↗
• MalfunctionMay 10, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR WHEN INSULIN RAN LOWER. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. TROUBLESHOOTING NOT PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8598967 ↗
• InjuryAug 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE NURSE REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 321 MG/DL. NO SYMPTOMS WERE NOTED, AND THE CUSTOMER WAS TREATED WITH AND IV DRIP. NURSE WAS UNSURE OF WHAT CAUSED THE HIGH BLOOD GLUCOSE LEVELS AND THE DEVICE HAD ALSO SUSPENDED. NO TROUBLESHOOTING OCCURRED. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7813637 ↗
• InjuryAug 23, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2018 WITH BLOOD GLUCOSE OF OVER 600 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS VOMITING. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. CUSTOMER REPORTED HE WOKE UP WITH THE HIGH BLOOD GLUCOSE OF 585 MG/DL. CUSTOMER'S BLOOD GLUCOSE READING WAS 88 MG/DL T THE TIME OF CALL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP DRIVE SUPPORT CAP WAS STICKING OUT. 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 7808205 ↗
• InjuryJul 19, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 54 MG/DL. THEY WERE UNABLE TO CLEAR THE ALARM. 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: Hypoglycemia

  MAUDE report 7701774 ↗
• InjuryNov 27, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE DEVICE WAS NOT RETURNED.

  Patient problems: Hyperglycemia

  MAUDE report 7061208 ↗
• MalfunctionNov 17, 2017Battery Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED FAILED BATTERY TEST AND UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043053 ↗
• InjurySep 22, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 404 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE WAS 335 MG/DL. NOT ABLE TO CONTINUE WITH TROUBLESHOOT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6886942 ↗
• MalfunctionSep 21, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART AND EXTERNAL RAM ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT PUMP WAS NOT STORED OR NOT IN USE FOR AN EXTENDED PERIOD OF TIME. AFTER TROUBLESHOOTING FOR UNEXPECTED RESTART ALARM, CUSTOMER WAS ADVISED THE RESERVOIR WILL BE REPLACED. CUSTOMER DECLINED TROUBLESHOOTING FOR EXTERNAL RAM ERROR ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6885167 ↗
• InjuryJul 27, 2017High Test Results

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 487 MG/DL. CUSTOMER FEELS OK TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE READING. CUSTOMER CURRENT BLOOD GLUCOSE READING WAS 333 MG/DL. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF THE INCIDENT WAS 350 MG/DL. CUSTOMER TREATED THE HIGH BLOOD GLUCOSE READING WITH 8.0 UNITS OF BOLUS. CUSTOMER REPORTED THEY HAVE CONTACTED THEIR HEALTHCARE PROVIDER REGARDING THE HIGH BLOOD GLUCOSE READING. CUSTOMER DRIVE SUPPORT WAS NORMAL. CUSTOMER DECLINED TO CHECK FOR OCCLUSION, AIR BUBBLES AND BENT CANNULA. CUSTOMER PREFERS CHANGING THE SET BY THEMSELVES. CUSTOMER DECLINED TO CHECK ON THE INSULIN PUMP SETTING. CUSTOMER DID NOT PERFORM HIGH PRESSURE TEST. PRODUCTS WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6747959 ↗
• InjuryJul 12, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAS BEEN DROPPED PRIOR TO BUTTON ERROR ALARM AND THE BUTTONS WERE UNRESPONSIVE. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A HIGH BLOOD GLUCOSE OF 500 MG/DL. CUSTOMER DID NOT MENTION ANY FORM OF TREATMENT FOR THE HIGH BLOOD GLUCOSE EVENT AND NO TROUBLESHOOTING WAS PERFORMED. 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 6709498 ↗

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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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