Paradigm® REAL-Time Revel™ MMT-523NAH (UDI 00643169077652)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169077652), received between Jun 6, 2017 and Mar 7, 2019 — classified as 4 injuries, 4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 300 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE WAS 400 MG/DL. THE CUSTOMER WAS TREATED WITH INJECTIONS. THE CUSTOMER HAD SYMPTOMS SUCH AS EXTREME THIRST AND FATIGUE. THE CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE CUSTOMER WAS ADVISED TO CHANGE ENTIRE SET, RESERVOIR AND INSULIN AND TREAT PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8402499 ↗
• MalfunctionDec 27, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT RESERVOIR WAS BROKEN OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8199138 ↗
• MalfunctionOct 24, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT ALARM WHEN THE RESERVOIR WAS EMPTY AND THERE WAS FRACTURE ON TOP OF RESERVOIR AS WELL AS BUTTONS HAD TO PRESS MORE THAN ONCE. 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 7998572 ↗
• InjuryDec 15, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 48 MG/DL. THE CUSTOMER TREATED THEIR BLOOD GLUCOSE LEVEL BY DRINKING POP. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7123039 ↗
• MalfunctionAug 8, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 82 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED FILLING INSULIN PUMP AND RECEIVING THE ERROR. THE CUSTOMER DID TROUBLESHOOT THE ISSUE AND WAS UNABLE TO CLEAR THE ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6775922 ↗
• MalfunctionJul 28, 2017Moisture Damage; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 180 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AFTER IT HAS BEEN EXPOSED TO MOISTURE. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS NOT ADVANCING. 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: No Consequences Or Impact To Patient

  MAUDE report 6752419 ↗
• InjuryJun 9, 2017Break

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017, WITH AN UNKNOWN BLOOD GLUCOSE ON (B)(6) 2017 AND 26 MG/DL ON (B)(6) 2017, AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT FOR BOTH INCIDENTS. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT'S TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. LATER ON (B)(6) 2017, THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 500 MG/DL RELATED TO THEIR HIGH GLUCOSE INTAKE. THEY TREATED FOR THE HIGH WITH THE PUMP. THE CUSTOMER ALSO REPORTED THAT THE PUMP HAS A BROKEN OFF RESERVOIR TUBE LIP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6629640 ↗
• InjuryJun 6, 2017Break; Positioning Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017, WITH BLOOD GLUCOSE OF 13 MG/DL AT TIME OF THE INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 264 G/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT THE LOW BLOOD GLUCOSE. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS SEIZURES AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER SAW THEIR HEALTH CARE PROFESSIONAL AND HAD THEIR SETTINGS ADJUSTED. THE CUSTOMER ALSO REPORTED HIGH BLOOD GLUCOSE LEVELS CAUSED BY THE RESERVOIR NOT STAYING WITHIN ITS COMPARTMENT, WHICH WAS DAMAGED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6615759 ↗

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-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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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