PARADIGM® REAL-time MMT-722NAP (UDI 00885074419824)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885074419824), received between Jul 6, 2017 and Nov 13, 2019 — classified as 1 injury, 5 malfunctions.

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

• MalfunctionNov 13, 2019Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BUTTONS WERE HARDER TO PRESS AND REJECTING THE NEW BATTERIES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313903 ↗
• MalfunctionOct 22, 2018Date/Time-Related Software Problem; Date/Time-Related Software Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED BUTTON ERROR AND TIME CLOCK ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 207 MG/DL. THE CUSTOMER REPORTED THAT THEY HAD BUTTON ERROR. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS NOT ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7990943 ↗
• MalfunctionMay 1, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT DID THE REWIND AGAIN AND GOT THE COMPROMISED FORCE SENSOR SYSTEM ERROR AGAIN. 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 7475035 ↗
• InjuryNov 1, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 522 MG/DL AND COMPROMISED FORCE SENSOR SYSTEM. THE INSULIN PUMP IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6995249 ↗
• MalfunctionAug 3, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR SEVERAL TIMES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 127 MG/DL. THE DRIVE SUPPORT CAP WAS PROTRUDED. 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: No Consequences Or Impact To Patient

  MAUDE report 6765999 ↗
• MalfunctionJul 6, 2017Device Displays Incorrect Message; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 146 MG/DL. THE CUSTOMER WAS ASKED TO OBSERVE IF THE TIME CLOCK ADVANCES AND IT DOES. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART SHORTLY AFTER INSERTING A NEW BATTERY. THE ALARM RECURRED DURING TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO MONITOR THE INSULIN PUMP FOR FURTHER ISSUES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6689166 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-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-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