PARADIGM® REAL-time MMT-722NAB (UDI 00643169478510)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169478510), received between Jun 1, 2017 and Jul 10, 2020 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 10, 2020No Display/Image; Moisture or Humidity Problem; No Display/Image; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT WORKING AND NOT TURNING ON. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. THE DISPLAY WENT BLANK AFTER EXPOSURE TO MOISTURE. CUSTOMER STATED THAT THE INSULIN PUMP HAD CONSTANT TONE. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10256581 ↗
• MalfunctionNov 1, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT INSULIN PUMP HAD KEYPAD UNRESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 243 MG/DL. CUSTOMER SAID THAT INSULIN PUMP WAS NOT BUMPED OR DROPPED AND TIME CLOCK ADVANCED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9264991 ↗
• InjurySep 8, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED A HIGH BLOOD GLUCOSE VALUE OF 530MG/DL. CUSTOMER ALSO STATES THAT SCREEN WAS BLANK. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICES DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE VALUES. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7858379 ↗
• MalfunctionAug 27, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE INSULIN PUMP HAD MOTION SENSOR TEST FAILURE. THE BLOOD GLUCOSE LEVEL OF THE CUSTOMER WAS UNKNOWN. THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT UNABLE TO REWIND THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED AS THE INSULIN PUMP UN-CONFIGURED AND WAS NOT WORKING. THE INSULIN PUMP WILL RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821090 ↗
• MalfunctionAug 23, 2017Retraction Problem; Device Displays Incorrect Message; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE CUSTOMER INSULIN PUMP ALARMED MOTOR ERROR AND UNABLE TO REWIND. CUSTOMER¿S BLOOD GLUCOSE WAS 262 MG/DL AT THE TIME OF INCIDENT. IT WAS ALSO REPORTED THAT THE INSULIN PUMP DRIVE SUPPORT CAP WAS STICKING OUT. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815151 ↗
• MalfunctionJun 1, 2017Loose or Intermittent Connection; Device Displays Incorrect Message

  IT WAS REPORTED VIA PHONE CALL THAT THEY HAD RECEIVED A MOTOR ERROR ALARM AND HAD A LOOSE DRIVE SUPPORT CAP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6606420 ↗
• MalfunctionJun 1, 2017Device Displays Incorrect Message

  IT WAS REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST. NO INDICATION OF TROUBLESHOOTING AND ISSUE BEING RESOLVED. 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 6604706 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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-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