Paradigm® REAL-Time Revel™ MMT-523RNAL (UDI 00613994918635)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994918635), received between Aug 29, 2017 and Nov 1, 2018 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD A MOTOR ERROR, A BUTTON ERROR ALARM LAST JULY AND THERE WAS A CHIP ON RESERVOIR COMPARTMENT LIP. THE CUSTOMER¿S BLOOD GLUCOSE WAS 109 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8029519 ↗
• InjuryJun 18, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE 3 TIMES IN 36 HOURS DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 22 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 340 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED GLUCOSE TABLETS AND WAS GIVEN GLUCAGON TO TREAT. THE CUSTOMER EXPERIENCED HIGH SYMPTOMS SUCH AS DRY MOUTH. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7609579 ↗
• InjuryMar 22, 2018Break; Loose or Intermittent Connection

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 257 MG/DL TO OVER 600 MG/DL. THE CUSTOMER REPORTED THAT THE INFUSION SITE OF WHERE THE RESERVOIR GOES IN THE SEALER WAS BROKEN AND IT WAS HANGING LOOSE AND THE GASKET WAS GONE. THE CUSTOMER REPORTED THAT THE RESERVOIR COMES LOOSE WHEN ON THE INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. 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 7364538 ↗
• InjuryNov 30, 2017Device Displays Incorrect Message

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER RECEIVED WITH UNEXPECTED RESTART ALARM. CUSTOMER ALSO REPORTED WITH NO DELIVERY ALARM DURING PRIME. CUSTOMER STATED BLOOD GLUCOSE WHEN SHE GET UP WAS 500 MG/DL AND SOMETHING TRIED GIVING INSULIN AND SAID NO DELIVERY NO DELIVERY ALARM. THE BLOOD GLUCOSE WAS 519 MG/DL AT ETH TIME OF THE INCIDENT. THE BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. TROUBLESHOOTING STEPS WERE GUIDED FOR NO UNEXPECTED RESTART ALARM. ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER RECEIVED MOTOR ERROR AFTER CLEARING THE NO DELIVERY SO WENT TO TROUBLESHOOT FOR THE NO DELIVERY. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. CUSTOMER STATED SHE HAVE NOT TREATED FOR HIGH BLOOD GLUCOSE WILL GIVE SHOT WITH SYRINGE. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP SHOULD BE DISCONTINUED SINCE THERE WAS A MOTOR ERROR. THE CUSTOMER ADVISED TO REPLACE THE INSULIN PUMP. CUSTOMER ADVISED TO DISCONTINUE USE OF PUMP AND REFER TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7070975 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 400+MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE LEVELS BEGAN IN LESS THAN 24 HOURS. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH READINGS. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO CHANGE THE INFUSION SET, RESERVOIR AND INSULIN AND TO TREAT PER HEALTHCARE PROFESSIONAL'S RECOMMENDATION. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6858294 ↗
• InjuryAug 29, 2017Bent; Break; Failure to Deliver; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A NO DELIVERY ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 430 MG/DL. CUSTOMER ALSO REPORTED A BENT CANNULA AND PHYSICAL DAMAGE. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6828316 ↗

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-1749-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
• Z-1750-2026 · Feb 13, 2026 · Open, Classified
  Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)
• 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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