Paradigm® REAL-Time Revel™ MMT-523LNAH (UDI 00613994748812)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994748812), received between Aug 28, 2017 and Nov 17, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (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.

• MalfunctionNov 17, 2017No Display/Image; Loss of Power; Device Displays Incorrect Message

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER RECEIVED WITH UNEXPECTED RESTART ALARM. THE BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. BLOOD GLUCOSE WAS 227MG/DL. CUSTOMER CALLED IN STATED THAT HER PUMP WENT OFF, SHE CHANGED BATTERY, AND THE BATTERY IS FULL BUT IT SAYS THE RESERVOIR IS BLANK. PERFORMING TROUBLESHOOT AND THE UNEXPECTED RESTART ALARM OCCURRED AFTER BATTERY CHANGE. CUSTOMER STATES A TEMP BASAL WAS NOT PROGRAMMED BEFORE THE UNEXPECTED RESTART ALARM OCCURRED. CUSTOMER ADVISED TO REPLACE THE INSULIN PUMP. CUSTOMER ADVISED TO MONITOR THE PUMP AND THAT PATIENT MAY CONTINUE TO WEAR THE PUMP UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7042337 ↗
• InjuryAug 28, 2017Device Alarm System

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400 MG/DL. THE CUSTOMER STATED THEY ARE HAVING MULTIPLE ALARMS DURING NORMAL USE OF THE INSULIN PUMP. THE CUSTOMER WAS ASSISTED IN PERFORMING A SELF TEST. THE INSULIN PUMP PASSED. THE ERROR TABLE DOES NOT INDICATE A PUMP REPLACEMENT IS REQUIRED. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP.. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6826169 ↗

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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-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