PARADIGM® REAL-time MMT-522RNAB (UDI 00613994408938)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994408938), received between Aug 14, 2017 and Dec 26, 2019 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Application Interface Becomes Non-Functional Or Program Exits Abnormally” (1 report).

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.

• InjuryDec 26, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF UNDER 60 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN FOOD TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER INFORMATION WAS PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9522426 ↗
• MalfunctionApr 9, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD TOP OF BATTERY COMPARTMENT CAME OUT. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. 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 8494506 ↗
• MalfunctionAug 14, 2017Application Interface Becomes Non-Functional Or Program Exits Abnormally; No Display/Image; Loss of Power; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP STOPPED WORKING. THEY CHANGED THE BATTERY AND IT STARTED ALARMING AND BEEPING. THE CUSTOMER REPORTED THAT THE INSULIN PUMP¿S SCREEN FROZE TO THE NUMBER 2 AFTER THEY INSERTED THE BATTERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. TROUBLESHOOTING WAS PERFORMED. THEY DID NOT SEE THE TIME CLOCK. THE SCREEN WAS NOT COMPLETELY BLANK. THEY WERE ADVISED TO INSERT A NEW BATTERY. THEY WERE ADVISED TO MONITOR THE INSULIN PUMP FOR 3 MINUTES TO VERIFY TIME CLOCK WORKS PROPERLY AND FROZEN DISPLAY, OR ALARMS, DO NOT RECUR. THE CUSTOMER STATED THAT THE SCREEN WAS STILL FROZEN WITH THE NUMBER 2 ON IT. THE DEVICE WILL BE REPLACED AND RETURNED FOR ANALYSIS DUE TO COSMETIC DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6791716 ↗

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-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-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-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-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