Paradigm® REAL-Time Revel™ MMT-523LNAS (UDI 00613994748843)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994748843), received between Jan 4, 2018 and Feb 14, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• InjuryFeb 14, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2018 WITH BLOOD GLUCOSE OF OVER 600 MG/DL. CUSTOMER STATED THAT HE WAS AT WORK WHEN HE NOTICED THAT HIS BLOOD GLUCOSE WAS RISING. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD SEVERAL NO DELIVERY AND MOTOR ERROR ALARMS. AND NO TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS NAUSEA, VOMITING, AND DIABETIC KETOACIDOSIS. THE CUSTOMER WAS TREATED WITH IV DRIP AND MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE WAS 530 MG/DL AT THE TIME OF INCIDENT AND TREATED WITH INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 7269834 ↗
• MalfunctionJan 4, 2018Break; Device Slipped

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE TOP OF THE RESERVOIR COMPARTMENT WAS DAMAGED AND THE RESERVOIR IS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP. THE BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7166555 ↗

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