Paradigm® REAL-Time Revel™ MMT-523NAS (UDI 00643169693760)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169693760), received between Aug 10, 2017 and Oct 17, 2019 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2019Computer Software Problem; Power Problem; Computer Software Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SOFTWARE ERROR BAD POINTER, IMPOSSIBLE DEFAULT CASE, PARAMETER OUT OF RANGE AND OFF NO POWER. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 140 MG/DL. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD OFF NO POWER ALARM AND DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE OFF NO POWER ALERT. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP REWIND. IT WAS ALSO REPORTED THAT THE NEW BATTERY RESOLVED THE OFF NO POWER ISSUE AND SOFTWARE ERROR BAD POINTER, IMPOSSIBLE DEFAULT CASE, PARAMETER OUT OF RANGE AND OFF NO POWER OCCURRED RIGHT AFTER A BATTERY CHANGE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9200991 ↗
• MalfunctionAug 1, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE LESS RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP REWIND IS LOUDER AND RECEIVED LOW BATTERY ALERT BEFORE A WEEK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849715 ↗
• InjurySep 11, 2018No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE OF THE PATIENT IS UNKNOWN. CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. TROUBLESHOOTING WAS NOT PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7863445 ↗
• InjuryMay 30, 2018Device Operates Differently Than Expected

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 169 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN GLUCOSE SOLUTION TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS BEING BELLIGERENT AND UNRESPONSIVENESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER REPORTED UNRESPONSIVE BUTTONS ON THEIR PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7551834 ↗
• InjuryDec 29, 2017Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 43 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 163 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED AND THE CUSTOMER BELIEVES THE PUMP OVER DELIVERED INSULIN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7155944 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL AND LOW BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 37 MG/DL AT THE TIME OF THE INCIDENT AND 508 MG/DL BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE. CUSTOMER WILL NOT RETURN DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7052715 ↗
• InjuryAug 10, 2017Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 490 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE READING. CUSTOMER WILL CALL BACK IF THE BLOOD GLUCOSE READING DO NOT REDUCE. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6786631 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-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-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