Paradigm® REAL-Time Revel™ MMT-723RNAP (UDI 00613994748744)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994748744), received between Jul 14, 2017 and Nov 20, 2019 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2019No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 454 MG/DL AT THE TIME OF INCIDENT AND OTHER BLOOD GLUCOSE WAS 340 MG/DL. CUSTOMER REPORTED THAT THEY RECEIVED STUCK BUTTON. CUSTOMER STATED THAT NOTHING COMES UP ON THE INSULIN PUMP EVEN IF SHE PRESSES ANY BUTTON. CUSTOMER STATED THAT ABOUT 5.00 AM THREW UP SINCE HER BLOOD GLUCOSE WAS AT 340 MG/DL AND STATED THAT INSULIN PUMP DID NOT GAVE HER BOLUS THEN GOT UP TO 454 MG/DL. CUSTOMER STATED THAT SHE WAS STUCK ON MAIN SCREEN. CUSTOMER TRIED TO PRESS ALL THE BUTTON ON THE DEVICE BUT NO RESPONSE ALSO STATED THAT CLIP BROKE AND INSULIN PUMP FELL OFF FROM WAIST AND GOT CRACK AND DAMAGED AT RESERVOIR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9347239 ↗
• MalfunctionMay 3, 2019Power Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BATTERY LIFE ISSUE AND STOPPED NO POWER, PUT IN A BRAND NEW BATTERY AND IT DID NOTHING. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THEY DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER STATES THE BATTERY WAS NOT PREVIOUSLY USED. CUSTOMER REPORTS THE INSULIN PUMP WAS NOT DROPPED. CUSTOMER STATES THERE WERE NOT UNATTENDED ALARMS. CUSTOMER STATES THE BATTERY CAP WAS NOT LOOSE, CRACKED OR DAMAGED. CUSTOMER STATES THIS WAS NOT THE SECOND OCCURRENCE OF OFF NO POWER WITHOUT A LOW BATTERY WARNING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576786 ↗
• MalfunctionDec 4, 2018Premature Discharge of Battery; Mechanical Problem; Unexpected Shutdown; Premature Discharge of Battery; Mechanical Problem; Unexpected Shutdown

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND PUMP ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. 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 8127928 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S DAUGHTER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE LOW BLOOD GLUCOSE LEVEL. THE BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS 41 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER'S OTHER RELEVANT BLOOD GLUCOSE LEVEL WAS 365 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7693518 ↗
• MalfunctionMay 30, 2018Component Missing; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT PIECE WAS MISSING AT THE RESERVOIR CHAMBER. BLOOD GLUCOSE WAS 300 MG/DL. TROUBLESHOOTING WAS PERFORMED. RESERVOIR WAS NOT STAYING IN THE INSULIN PUMP. 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: Hyperglycemia

  MAUDE report 7552192 ↗
• InjuryNov 22, 2017No Audible Alarm; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP SCREEN WAS HARD TO READ AND THE AUDIO DOES NOT WORK. THE CUSTOMER ALSO REPORTED THAT THEY WERE HAVING LOW BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER DECLINED TO TROUBLESHOOT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7053257 ↗
• MalfunctionNov 15, 2017No Display/Image; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP ALARMED FAILED BATTERY TEST ALARM AND HAD BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 122 MG/DL AT THE TIME OF THE INCIDENT. IT ALSO REPORTED THAT THE CUSTOMER WAS ADVISED TO INSERT THE NEW BATTERY AND CUSTOMER RECEIVED FAILED BATTERY TEST. THE CUSTOMER REPORTED THAT THE SPRING WAS NEITHER DAMAGED NOR CORRODED. 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 7035038 ↗
• MalfunctionSep 26, 2017Inaccurate Delivery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 317 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. CUSTOMER STATED THEY WERE UNABLE TO EXIT THE "PREPARING TO PRIME" LOOP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED 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 6895303 ↗
• InjuryAug 24, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL 500 MG/DL. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS. CUSTOMER IS TREATING HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 285 MG/DL AT THE TIME OF THE CALL. CUSTOMER DID NOT REPORT WHEN THE HIGH BLOOD GLUCOSE LEVELS BEGAN ON. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. THE CUSTOMER STATES INSULIN PUMP KEEPS RECEIVING FAIL BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6817973 ↗
• InjuryJul 28, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 44 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND THE ACT BUTTON WAS UNRESPONSIVE. NO SIGNIFICANT EVENT LEADING TO BUTTON ERROR OR KEYPAD ANOMALY WERE OBSERVED. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A LOW BLOOD GLUCOSE OF 44 MG/DL AND TREATED WITH FOOD. NO LOW BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED DUE TO KEYPAD ANOMALY. 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: Hypoglycemia

  MAUDE report 6752722 ↗
• InjuryJul 14, 2017Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL LOW BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IN THE 40 MG/DL RANGE. CUSTOMER TREATED THEIR LOW BLOOD GLUCOSE WITH SUGAR TABLETS AND FOOD.

  Patient problems: Hypoglycemia

  MAUDE report 6715430 ↗

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-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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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