Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00643169693753)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169693753), received between Sep 27, 2017 and Aug 11, 2020 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2020No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN WENT BLANK AND GOT POWER LOSS ALARM. CUSTOMER STATED THEY PUT BATTERY BUT THERE WERE ICON WITH DOT APPEARS. CUSTOMER WERE ABLE TO CLEAR THE ALARM BUT DID NOT RECEIVE REQUEST TO REWIND INSULIN PUMP. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10390154 ↗
• InjuryMay 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. THE CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER REPORTED THAT THEY TREATED HIGH BLOOD GLUCOSE LEVEL WITH THE MANUAL INJECTIONS. THE CUSTOMER DID NOT MENTION ANY SYMPTOM RELATED TO HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP PASSED THE SELF TEST. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8643403 ↗
• MalfunctionMay 3, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD OVER DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 66 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE VALUE WITH FOOD. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. THE CUSTOMER WAS NOT USING THE INSULIN PUMP WHEN EVENT WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8577164 ↗
• MalfunctionMar 14, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP AND INSULIN SQUIRTED OUT IF THE TUBING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE WAS 135 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED INSULIN SQUIRTING OUT DURING THE PRIME PROCESS. THE CUSTOMER INDICATED THE DRIVE SUPPORT CAP WAS NORMAL. 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 8419642 ↗
• MalfunctionSep 19, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT IT WAS HARD TO READ AND DURING REWINDING WORKING HARD. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7890583 ↗
• MalfunctionSep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 338 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7844160 ↗
• InjuryJun 19, 2018Detachment Of Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INFUSION SET TUBING WAS DETACHED. THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL. THE CUSTOMER TREATED WITH INSULIN SHOT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7614305 ↗
• InjuryMar 22, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 53 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARM AND IT WAS FOUND DURING TROUBLESHOOTING THAT THE INSULIN EXITED. THE CUSTOMER REPORTED THAT THE NO DELIVERY ALARM RECURRED. THE CUSTOMER REPORTED THAT THEY TRIED ALL REMEDIES. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7364568 ↗
• InjuryMar 8, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 42 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE WAS 512 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH FOOD AND GLUCOSE TABLETS. CUSTOMER WILL NOT RETURNED DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7326058 ↗
• MalfunctionMar 2, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED THE FAILED BATTERY TEST. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 68 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING FOR FAILED BATTERY TEST. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7309840 ↗
• MalfunctionFeb 20, 2018Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS OVER DELIVERING INSULIN AND CAUSING LOWS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 71 MG/DL AT THE TIME OF THE INCIDENT, AND 103 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED JUICE TO TREAT THE LOW. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER STATED THE PUMP HAD BEEN EXPOSED TO MAGNETIC FIELDS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7282548 ↗
• InjuryFeb 16, 2018Insufficient Device Problem Information

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 472 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7278356 ↗
• InjurySep 27, 2017Failure to Deliver; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD NO DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 325 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT BLOOD GLUCOSE WAS 336 MG/DL. THE CUSTOMER STATED THAT THEY HAD A HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE CUSTOMER WAS ADVISED TO CHECK THE INSULIN VIAL AND WAS ALSO ADVISED CUSTOMER TO CHANGE SET. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6899311 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-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-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-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-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