Paradigm® REAL-Time Revel™ MMT-523RNAH (UDI 00613994918642)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994918642), received between Aug 22, 2017 and Jun 7, 2019 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2019Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP UP BUTTON WAS NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO STATED THAT THE INSULIN PUMP TIME ADVANCES. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677821 ↗
• InjuryOct 26, 2017Failure to Deliver; Device Displays Incorrect Message

  CUSTOMER'S SPOUSE REPORTED VIA PHONE CALL THAT CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 521 MG/DL. THE CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 521 MG/DL AT THE TIME OF THE CALL. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. CUSTOMER'S SPOUSE ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY AND MOTOR ERROR ALARM. THE CUSTOMER 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. THE CUSTOMER WAS ADVISED TO 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 6981763 ↗
• InjurySep 5, 2017Inaccurate Delivery

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE SO LOW THAT A METER COULDN'T READ IT AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 230 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED FOOD TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED AND THE CUSTOMER BELIEVES THE PUMP OVER DELIVERED INSULIN. THE CUSTOMER ALSO STATED THAT THEY FELT THE PUMP OVER DELIVERING SO THEY ATE BREAD AND A TEASPOON OF HONEY TO TREAT. THE CUSTOMER ALSO STATED THEY WERE HAVING HIGHS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6842991 ↗
• MalfunctionAug 22, 2017Break; Detachment Of Device Component

  THE CUSTOMER MENTIONED THAT HER INSULIN PUMP IS CHIPPED WHERE THE RESERVOIR COMPARTMENT IS AND WHEN SHE CHANGED IT THE O - RING CAME OUT. THE CUSTOMER IS UNSURE HOW IT HAPPENED. THE CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN. THE INSULIN PUMP WILL RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6810481 ↗

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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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