Paradigm® REAL-Time Revel™ MMT-523NAH (UDI 00613994743855)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994743855), received between May 15, 2017 and Sep 23, 2019 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 115 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER REPORTED THAT DURING MANUAL PRIME THE INSULIN PUMP SPRAYS OUT INSULIN INSTEAD OF DROPS. THE CUSTOMER REPORTED THAT ALARM OCCURRED DURING MANUAL PRIME. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9102507 ↗
• InjuryMar 15, 2019Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 350 MG/DL AT THE TIME OF THE INCIDENT. CURRENT BLOOD GLUCOSE WAS 435 MG/DL THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. CUSTOMER HAS NOT BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER WAS TREATED WITH INSULIN PUMP AND SYRINGES. CUSTOMER WILL BE RETURNED DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8423534 ↗
• InjuryOct 20, 2018No Display/Image; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP ALARMED BATTERY-OUT LIMIT AND NEW BATTERY QUITS SUDDENLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD MOTOR POWER FAILURE ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7988016 ↗
• MalfunctionAug 9, 2018No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSULIN PUMP RECEIVED A SOFTWARE ERROR ALARM. BLOOD GLUCOSE WAS UNKNOWN AT TIME OF INCIDENT. TROUBLESHOOTING WAS COMPLETED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE CUSTOMER WILL RECEIVE A REPLACEMENT INSULIN PUMP AND WILL RETURN THE ONE THEY CURRENTLY USE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7768354 ↗
• InjuryJun 14, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE BUTTONS WERE NOT RESPONSIVE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 28 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7600099 ↗
• InjurySep 7, 2017Moisture Damage; Scratched Material

  CUSTOMER REPORTED VIA PHONE CALL FOR HIGH BLOOD GLUCOSE AND FOR FOG UNDER THE SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. CUSTOMER REPORTED THAT SHE WAS OVER 400 MG/DL AND WHEN THEY CHECKED AGAIN SHE WAS DOWN 300+ MG/DL. CUSTOMER REPORTED THAT SCREEN IS ALL FOGGED UP, SCRATCH SCREEN. CUSTOMER DIDN¿T HAVE THE PUMP TO TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6850600 ↗
• InjurySep 1, 2017Battery Problem; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 570 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT AND UNABLE TO CLEAR THE ALARM DUE TO UNRESPONSIVE BUTTONS. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE THAT COULD HAVE LED TO KEYPAD ANOMALY. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A HIGH BLOOD GLUCOSE OF 570 MG/DL AND TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. CUSTOMER'S BLOOD GLUCOSE READING WAS AT 217 MG/DL THE MORNING PRIOR TO CALL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6837819 ↗
• InjuryAug 29, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AFTER THE BATTERY HAS BEEN CHANGED. NO SIGNIFICANT EVENT LEADING TO BUTTON ERROR OR KEYPAD ANOMALY WERE OBSERVED. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A HIGH BLOOD GLUCOSE OF 500 MG/DL AND TREATED WITH INSULIN PUMP. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6828462 ↗
• MalfunctionMay 15, 2017Fluid/Blood Leak

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP AND INSULIN SQUIRTED OUT OF THE TUBING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS 230 MG/DL AT THE TIME OF THE INCIDENT. DURING TROUBLESHOOTING, THE INSULIN PUMP WAS UNABLE TO EXIT THE PRIMING PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568253 ↗

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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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-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