PARADIGM® REAL-time MMT-722RNAB (UDI 00613994623898)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994623898), received between Dec 5, 2017 and Feb 11, 2020 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN THE HOSPITAL ON (B)(6) 2019. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2019 AND PRONOUNCED DECEASED THERE. THE CAUSE OF DEATH WAS REPORTED AS DIABETES, HEART FAILURE AND RENAL FAILURE. THE CALLER STATED THAT THE CUSTOMER HAD HEART AND RENAL FAILURE AS WELL AS ADDISON'S DISEASE THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF PASSING. THE CUSTOMER WAS USING A THIRD PARTY'S SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THIS CASE IS ONLY BEING REPORTED FOR THE MALFUNCTION DISCOVERED IN FAILURE ANALYSIS.

  Patient problems: Death

  MAUDE report 9694404 ↗
• MalfunctionDec 6, 2017Crack; Failure to Read Input Signal; Defective Component; Physical Property Issue

  THE CUSTOMER AND THE CUSTOMER'S SPOUSE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE AND ALSO A KEYPAD ANOMALY. TROUBLESHOOTING FOR BUTTON ERROR/KEYPAD ANOMALY WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE BOLUS BUTTON WAS UNRESPONSIVE. THE CUSTOMER ALSO STATED THAT THERE WAS NO SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUES AND THAT THE TIME ON THE CLOCK ADVANCED WHEN MONITORED FOR ONE MINUTE. HOWEVER, AFTER TROUBLESHOOTING, THE CUSTOMER REPORTED VIA EMAIL THAT THE TIME WAS FROZEN. TROUBLESHOOTING FOR DAMAGE FOUND THAT THERE WAS A CRACK NEAR THE RESERVOIR COMPARTMENT. THE CUSTOMER WAS UNSURE HOW THE DAMAGE OCCURRED. PER BOTH TROUBLESHOOTING, 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 INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7088494 ↗
• MalfunctionDec 5, 2017Crack; Device Inoperable; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS REPORTED THAT THE BUTTONS WERE DOES NOT WORKED AND INSULIN PUMP HAD CRACK NEAR RESERVOIR COMPARTMENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085596 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-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