PARADIGM® REAL-time MMT-522NAS (UDI 00613994312822)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994312822), received between Aug 29, 2017 and May 11, 2020 — classified as 1 death, 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS OF INSULIN PUMP WERE STICKY. CUSTOMER STATED THAT THE PLASTIC WAS CHIPPING OFF FROM THE AREA OF SCREW IN RESERVOIR. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD CHIPS AND CRACKS AROUND THE RESERVOIR COMPARTMENT BUT RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO THE INSULIN PUMP. 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 10043758 ↗
• MalfunctionOct 9, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT THEY WERE ABLE TO COMPLETE REWIND. THE TROUBLESHOOTING WAS PERFORMED AND CUSTOMER ALSO STATED THAT THEY DID NOT RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. CUSTOMER ALSO STATED THAT THEY EXPERIENCED MULTIPLE UNEXPECTED RESTART ALARMS AFTER BATTERY CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9170265 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 420 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER¿S OTHER BLOOD GLUCOSE WAS OVER 400 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. THE CUSTOMER HAS BEEN USING THE INSULIN PUMP WITHIN THE 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER STATED THAT THEY DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER STATED THAT INFUSION SET WAS LEAK AND HAD BENT CANNULA. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9149937 ↗
• MalfunctionJun 28, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR, ACT BUTTON STICKING. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743456 ↗
• DeathNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY ON THE WAY TO THE HOSPITAL EMERGENCY ROOM. THE CAUSE OF DEATH WAS CARDIO PULMONARY ARREST, ATHEROSCLEROSIS, AND DIABETES, BUT WAS ALSO THOUGHT TO BE A BLOOD CLOT. THE CALLER STATED THAT THE CUSTOMER HAD OPEN HEART SURGERY, BYPASS SURGERIES, SPINAL CYANOSIS, AND OSTEOPOROSIS THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S SENSOR GLUCOSE WAS 67 MG/DL AT THE TIME OF DEATH. THE LAST METER READING ON (B)(6) 2018 SHOWED 53 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CUSTOMER WAS USING A COMPETITOR'S SENSOR SYSTEM AND THE CALLER HEARD A LOW ALERT, BUT THE CUSTOMER WAS UNRESPONSIVE AT THAT TIME. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death; Hypoglycemia

  MAUDE report 8095045 ↗
• InjurySep 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 401 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS TRYING TO RECONNECT A SET THAT THEY HAD DISCONNECTED AT THE QUICK RELEASE. THE CUSTOMER HAD ISSUES RECONNECTING ANOTHER SET AS WELL. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE SET WAS REMOVED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7853614 ↗
• MalfunctionAug 21, 2018Power Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED PUMP ERROR ALARMS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 240 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WILL RETURN DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801362 ↗
• MalfunctionAug 3, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER BLOOD GLUCOSE LEVEL WAS 130 MG/DL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7746299 ↗
• MalfunctionFeb 16, 2018Fluid/Blood Leak; Device Inoperable

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND UNABLE TO CONFIRM IF THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED THAT THE INSULIN SQUIRTED OUT DURING PRIME/FILL PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7278199 ↗
• InjuryJan 22, 2018Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALERT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE ALARM OCCURRED DURING REWIND AND BATTERY AREA WAS DAMAGED. 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 INSULIN PUMP FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7210851 ↗
• InjuryDec 11, 2017Excess Flow or Over-Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BLOOD GLUCOSE WAS LOW. THE CUSTOMER¿S BLOOD GLUCOSE WAS 12MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED THAT HER PUMP BOLUSED 2U AND IT¿S NOT NORMAL. THE CUSTOMER HAD LOW BLOOD GLUCOSE AND THE PUMP WAS DELIVERING BOLUSES FOR ITSELF. THE CUSTOMER WAS ADVISED TO RETURN THE PRODUCT BUT THE CUSTOMER DECLINED. SHE TREATED LOW BLOOD GLUCOSE BY TAKING GLUCAGON SHOT. SHE DECLINED TROUBLESHOOTING. THE CUSTOMER STATED THE PUMP IS 10 YEARS OLD AND HAS BEEN GIVING BOLUSES BY ITSELF FOR ABOUT 6 MONTHS.

  Patient problems: Hypoglycemia

  MAUDE report 7105841 ↗
• InjuryNov 15, 2017Insufficient Device Problem Information

  EVENT DATE HAS BEEN CHANGED TO (B)(6) 2017 AND CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL SINCE SUNDAY.

  Patient problems: Hypoglycemia

  MAUDE report 7033323 ↗
• MalfunctionAug 29, 2017Device Alarm System

  CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED COMPROMISED FORCED SENSOR SYSTEM DURING PRIME FILL PROCESS. CUSTOMER REPORTED THAT THE FORCE SENSOR DOES NOT DETECT THE RESERVOIR. CUSTOMER'S BLOOD GLUCOSE READING WAS 115 MG/DL. ADVISED DISCONTINUATION OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. PRODUCT IS BEING RETURNED AND REPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6827547 ↗

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