PARADIGM® REAL-time MMT-722RNAP (UDI 00613994409164)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00613994409164), received between Jul 21, 2017 and Sep 28, 2018 — classified as 3 injuries, 2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 212 MG/DL. DRIVE SUPPORT CAP WAS STICKING OUT. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7917515 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF MG/DL 46 MG/DL. CUSTOMER FEEL OK TO TROUBLESHOOT. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BG EVENT. DRIVE SUPPORT WAS NORMAL. CUSTOMER BLOOD GLUCOSE READING AT THE TIME OF INCIDENT WAS 46 MG/DL. CUSTOMER'S BLOOD GLUCOSE READING WAS 197 MG/DL AT THE TIME OF CALL. CUSTOMER LOW BLOOD GLUCOSE READING WAS TREATED WITH FOOD. CUSTOMER DID NOT REPORT OVER DELIVERY. CUSTOMER TREATED THEIR BLOOD GLUCOSE READING WITH GLUCOSE TABLETS. CUSTOMER CHANGED THEIR SET ON JUNE 25, 2018. CUSTOMER WAS ADVISED TO CALL THEIR HEALTHCARE PROVIDER. THE INSULIN PUMP HAD POWER LOSS, LOW BATTERY ALERT LESS THAN A WEEK AND UNEXPECTED RESTART. THE PRODUCT WAS NOT RETURNED.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7717050 ↗
• MalfunctionNov 21, 2017Crack; Loose or Intermittent Connection; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND DRIVE SUPPORT CAP WAS LOOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE SCREEN HAD LITTLE CRACK. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7051451 ↗
• InjuryAug 2, 2017Structural Problem; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED ON (B)(6) 2017 AT ABOUT 2:30 A.M. DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS. THE CUSTOMER STATED THAT WHEN SHE WOKE UP ONE MORNING SHE FELT LETHARGIC AND COULD NOT BREATH. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS 1204 MG/DL. THEY WERE TREATED WITH INSULIN DRIP, INTRAVENOUS FLUIDS, AND SHE WAS SWITCHED TO MANUAL INJECTIONS. THEIR CURRENT BLOOD GLUCOSE LEVEL WAS 360 MG/DL. TROUBLESHOOTING WAS PERFORMED. IT WAS NOTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THEY DID NOT RECALL PRESSING THE CAP WHILE CONNECTED. THE 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 PRODUCT FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 6761149 ↗
• InjuryJul 21, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM WHEN THEY TRIED TO PRIME THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL DURING THE INCIDENT WAS 575 MG/DL. THE CUSTOMER¿S RECENT BLOOD GLUCOSE LEVEL WAS 468 MG/DL. THEY HAD BEEN OFF THE INSULIN PUMP FOR THE LAST 2 DAYS AND WAS TREATING WITH SYRINGES. THEY DID NOT HAVE THE INSULIN PUMP WITH THEM AT THE TIME OF THE CALL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6732271 ↗

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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-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