Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00613994904294)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00613994904294), received between Jun 6, 2017 and Dec 23, 2019 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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.

• MalfunctionDec 23, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE UP BUTTON WAS STICKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9510268 ↗
• MalfunctionNov 29, 2019Moisture or Humidity Problem; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP GOT WET. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS NOT TRUST HER INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9391467 ↗
• MalfunctionJan 7, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE CUSTOMER REPORTED THAT SHE HAD DROPPED HER PUMP MANY TIMES AND HAD BROKEN PIECES. THE CUSTOMER REPORTED THAT THE LIP RING WAS DAMAGED. THE CUSTOMER REPORTED THAT THE RESERVOIR COMPARTMENT WAS NOT SECURED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8221117 ↗
• MalfunctionNov 1, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD REWIND ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT INSULIN SQUIRTING OUT. THE CUSTOMER REPORTS THAT INSULIN PUMP[ HAD FAILED BATTERY TEST ALARM AND INSULIN PUMP REJECTED THE NEW BATTERY. THE CUSTOMER ALSO REPORTED THAT INSULIN PUMP GIVES THE NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8029844 ↗
• MalfunctionAug 30, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME LOOP. THE PATIENT¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7832266 ↗
• InjuryAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 407 MG/DL AT THE TIME OF INCIDENT. CUSTOMER TREATED WITH PEN. CUSTOMER ALSO REPORTED THAT CRACK ON RESERVOIR. TROUBLESHOOTING DECLINED FOR HIGH BLOOD GLUCOSE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. CONCOMITANT PRODUCT: FRN MMT- 326 A MMT- 399.

  Patient problems: Hyperglycemia

  MAUDE report 7800388 ↗
• InjuryDec 7, 2017Structural Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL AND THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 478 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7096467 ↗
• InjuryJun 12, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 415 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL AT THE TIME OF CALL. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE CUSTOMER PERFORMED TROUBLESHOOTING AND DID NOT FIND AIR BUBBLES, LEAKS, SITE AND INSULIN ISSUES AND SETTING ISSUES. THE CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR, INSULIN AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6634511 ↗
• MalfunctionJun 6, 2017Sticking; Structural Problem

  CUSTOMER VIA PHONE CALL STATED THAT DAUGHTER'S PUMP HAD AN ESC BUTTON THAT WAS GETTING STUCK. CUSTOMER STATES THE PUMP IS ALMOST 7 YEARS OLD AND THIS HAD BECOME A PROBLEM. NOW THE BUTTON WILL NOT POP UP AND CANNOT PROPERLY COMPLETE HER SET CHANGE AND IS USING A SHARP OBJECT TO PRESS THE PUMP BUTTON. BUTTON/KEYPAD ANOMALY TROUBLESHOOT WAS DONE AND IT WAS DETERMINED THAT THE PUMP WAS GOING TO NEED TO BE RETURNED. CUSTOMER WAS ADVISED TO REVERT TO BACK UP PLAN PER HCP'S INSTRUCTIONS. CUSTOMER'S BLOOD GLUCOSE WERE NOT MENTIONED AT THE TIME OF THE CALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616834 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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