PARADIGM® REAL-time MMT-522NAP (UDI 00613994402103)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994402103), received between Sep 18, 2017 and Aug 11, 2020 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2020Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BOLUS BUTTON HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERIES AND UNEXPLAINED NO INSULIN DELIVERY ALERT. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD SQUIRTS ON PRIME, CRACK ON RESERVOIR. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10389318 ↗
• MalfunctionMar 3, 2020Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SCREEN HAD BLACK LINE ACROSS IT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARMS. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD CRACK AND THE INSULIN PUMP WAS REJECTED THE NEW BATTERY. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9778723 ↗
• MalfunctionNov 14, 2019Mechanical Problem; Moisture or Humidity Problem; Mechanical Problem; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND INSULIN PUMP EXPOSED TO MOISTURE. THE 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 9320501 ↗
• InjuryDec 30, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. THE CUSTOMER ALSO REPORTED THAT THEIR INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8205639 ↗
• MalfunctionNov 1, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 280 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8029540 ↗
• InjuryJul 3, 2018Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A MOTOR ERROR ALARM AFTER THEIR BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL. THE CUSTOMER DID NOT SPECIFY TREATMENT FOR THE PUMP. THE CUSTOMER STATED THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7657904 ↗
• MalfunctionJun 20, 2018Device Alarm System; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN DOES SHOOT WHEN PRIMING INSTEAD OF DRIPPING OUT AND LOUDER DURING REWIND AS WELL AS INSULIN PUMP FAILED TO ALARM WHEN INSULIN LOW WITHIN PAST 6 MONTHS A FEW TIMES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7622343 ↗
• MalfunctionMay 30, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM AS WELL AS PRIME REWIND. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 187 MG/DL. TROUBLESHOOTING WAS PERFORMED FOR PRIME REWIND. THE CUSTOMER ALSO STATED THAT THE BOTTOM OF THE PUMP WAS COMING LOOSE. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7552455 ↗
• MalfunctionMar 30, 2018Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM AND DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 115 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7386748 ↗
• MalfunctionFeb 9, 2018Device Displays Incorrect Message; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD AN UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THEY CHANGED BATTERY AND RECEIVED AN UNEXPECTED RESTART ALARM. THE CUSTOMER ADVISED TO MONITOR THE PUMP AND CALL IF ISSUES RECUR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7259956 ↗
• MalfunctionFeb 7, 2018Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY AND UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATES THE BATTERY CAP MAY BE LOOSE, CRACKED OR DAMAGED. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7249303 ↗
• InjuryFeb 2, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED UNEXPECTED RESTART AND EXTERNAL RAM CRC ERROR ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7239051 ↗
• InjuryJan 17, 2018Bent; Crack; Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE OVER 600MG/DL. CUSTOMER STATED THAT SHE HAD NO DELIVERY. CUSTOMER ALSO REPORTED THAT THEY HAD BENT CANNULA AND HAD CRACK ON INSULIN PUMP. DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7202726 ↗
• MalfunctionSep 18, 2017Break; Moisture Damage

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE AND WAS BROKEN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 88 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT EXPOSURE WAS POOL WATER AND THAT THERE WAS FLUID UNDER THE LCD DISPLAY. THE CUSTOMER ALSO ADDED THAT THE INSULIN PUMP HAD SOME CRACKS. 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 6873616 ↗

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-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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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