PARADIGM® REAL-time MMT-722NAL (UDI 00613994223722)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994223722), received between Dec 27, 2017 and Mar 11, 2019 — classified as 4 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 (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SQUIRTING INSULIN DURING THE MANUAL PRIME PROCESS AND HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE INSULIN PUMP HAD SCRATCHES ON THE SCREEN AND THE MOTOR SEEMS LIKE IT STOPS IN THE MIDDLE OF REWIND AND THEN STARTS AGAIN. CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM UNDELIVERED ALARM ALERTS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8407616 ↗
• MalfunctionJul 9, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY STUCK IN PREPARING PRIME LOOP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 AND 288 MG/DL. THE DEVISE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7670682 ↗
• MalfunctionJun 7, 2018Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS AS WELL AS THEY WERE RECEIVING PUMP ERROR ALARM AND THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. 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: Hyperglycemia

  MAUDE report 7577081 ↗
• MalfunctionDec 27, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 136 MG/DL AT THE TIME OF THE INCIDENT. IT WAS REPORTED THAT THE CUSTOMER TRIED TO PRIME THE INSULIN PUMP AND WAS GETTING AN COMPROMISED FORCE SENSOR SYSTEM ERROR MESSAGE AND IT WILL NOT CLEAR OUT. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND TO REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7149712 ↗

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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-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