Paradigm® REAL-Time Revel™ MMT-523KNHRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994743756), received between Mar 23, 2018 and Oct 28, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2019Device Difficult to Program or Calibrate; Power Problem; Device Difficult to Program or Calibrate; Power Problem

  CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD KEYPAD ANOMALY AND BATTERY OUT LIMIT. CUSTOMER¿S BLOOD GLUCOSE WAS 138 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 336 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THEY WERE NOT ABLE TO CLEAR THE ALARM CUSTOMER STATED THAT NUMBERS ARE RAMPING ON THEIR OWN. CUSTOMER STATED THE SCROLL BAR IS NOT MOVING WITH NO INPUT. THE INSULIN PUMP WAS NOT EXPOSED TO A CHANGE IN ALTITUDE. ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9243533 ↗
• InjuryMar 23, 2018Device Displays Incorrect Message

  THE CALLER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD SEVERAL MOTOR ERROR ALARMS AND HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 468 MG/DL AT THE TIME OF THE INCIDENT. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER HAD A HIGH BLOOD GLUCOSE OF 468 MG/DL AND TREATED. NO HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. THE CALLER WAS ADVISED TO HAVE CUSTOMER DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7365703 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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