PARADIGM® REAL-time MMT-522RNAB (UDI 00613994623553)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994623553), received between Jan 29, 2018 and Mar 27, 2019 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 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 ESC AND ACT BUTTONS HARD TO PRESS AS WELL AS INSULIN PUMP REJECTING THE NEW BATTERIES ALSO RANDOM NO DELIVERY ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455067 ↗
• InjuryFeb 28, 2018Failure to Prime; Device Displays Incorrect Message

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALERT WITH PRIME REWIND ANOMALY. THE BLOOD GLUCOSE WAS 458 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT, THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER STATED THAT, THE REWIND MESSAGE OCCURRED AFTER AN ALARM AND THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THEY ARE UNABLE TO DESCRIBE ANY POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP. CUSTOMER TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS WITH INSULIN. TROUBLESHOOTING DETERMINED THAT, THE INSULIN PUMP SHOULD BE REPLACED. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7303776 ↗
• InjuryJan 29, 2018Device Displays Incorrect Message

  IT WAS REPORTED BY THE CUSTOMER'S NEXT OF KIN THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 368 MG/DL AT THE TIME OF ADMISSION. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS CONSTANTLY NEEDING TO USE THE BATHROOM. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT, BUT IT WAS REMOVED BY THE DOCTORS. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER ALSO HAD SOME LOWS BEFORE THE HIGH BLOOD GLUCOSE. THE CUSTOMER HAD PNEUMONIA AS WELL. THE CALLER ALSO REPORTED NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7226759 ↗

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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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