PARADIGM® REAL-time MMT-722RNAS (UDI 00613994623935)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994623935), received between Jun 8, 2017 and Aug 10, 2020 — classified as 1 death, 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS NOT PROVIDED. THE CALLER STATED THAT THE CUSTOMER HAD CORONARY PULMONARY ISSUES AND DIABETES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CALLER DECLINED TO PROVIDE FURTHER INFORMATION. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. IT IS UNKNOWN IF THE CUSTOMER WAS USING SENSORS. THE CALLER DID NOT STATE WHETHER THEY WOULD RETURN THE INSULIN PUMP FOR ANALYSIS, BUT UNEXPECTEDLY RETURNED IT. THIS REPORT WAS MADE FOR THE FAILURE ANALYSIS RESULTS.

  Patient problems: Death

  MAUDE report 10383406 ↗
• InjuryJul 9, 2020Overheating of Device; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem; Overheating of Device; Device Difficult to Program or Calibrate; Date/Time-Related Software Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY, TIME CLOCK ANOMALY, OVERHEATING ANOMALY AND THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 585 MG/DL. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE LEVEL VIA MANUAL INJECTION. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED THE BUTTONS WERE UNRESPONSIVE, THE INSULIN PUMP OVERHEATED AND THE TIME CLOCK ADVANCED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10249420 ↗
• InjuryJul 9, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 585 MG/DL AND THE CURRENT BLOOD GLUCOSE WAS 169 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH MANUAL INJECTION AND DECLINED TROUBLESHOOTING FOR IT. THE CUSTOMER ALSO STATED THAT, THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER STATED THAT, HER BUTTONS STOP WORKING YESTERDAY BUT HAS HAD ISSUES THE PAST COUPLE OF YEARS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10249105 ↗
• InjuryJul 8, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE THE CUSTOMER'S BLOOD GLUCOSE WAS 585 MG/DL. THE CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. IT WAS STATED THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. IT WAS STATED THAT FOR PAST COUPLE OF YEARS BUTTONS HAVE SEEMED TO GET STUCK BUT YESTERDAY STOPPED WORKING COMPLETE WHILE TRYING TO CHANGE RESERVOIR. THE CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND FOUND THE TIME CLOCK WAS ADVANCING. IT WAS STATED THAT THERE WERE CRACKS ON INSULIN PUMP WHERE RESERVOIR GOES AND ALONG THE SIDE AND THE BATTERY AREA HAS FALLEN OFF. THE CUSTOMER DECLINED TROUBLESHOOTING FOR CRACKS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10244033 ↗
• MalfunctionApr 9, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9942316 ↗
• MalfunctionDec 24, 2019Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND RANDOM NO DELIVERY ALARM. 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 9514758 ↗
• InjuryJun 6, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 69 MG/DL. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS APPEARED NORMAL. THE CUSTOMER WAS UNABLE TO TROUBLESHOOT FOR LOW BLOOD GLUCOSE LEVEL. 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: Hypoglycemia

  MAUDE report 7572520 ↗
• InjuryJun 5, 2018Insufficient Device Problem Information

  CUSTOMER¿S WIFE REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 597MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7571585 ↗
• DeathDec 20, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2013. THE CAUSE OF DEATH WAS CARDIAC ARRYTHMIA, ACUTE MYOCARDIAL INFARCTION, CKD STAGE 4, AND INSULIN DEPENDENT DIABETES. THE CALLER STATED THAT THE CUSTOMER HAD OTHER ILLNESSES THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE CALLER IS UNSURE IF THE CUSTOMER WAS USING SENSORS. THE CALLER HAD ALREADY RETURNED THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 7133932 ↗
• MalfunctionNov 8, 2017Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA EMAIL THAT INSULIN PUMP WAS NOT WORKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT TIME OF INCIDENT. INSULIN PUMP WILL BE REPLACED. INSULIN PUMP WILL NOT BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7011621 ↗
• InjuryNov 6, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED ON (B)(6) 2017 DUE TO CAR ACCIDENT AND LOW AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE WAS 169 MG/DL. CUSTOMER REPORTED ABOUT 6 MONTHS AGO HE WAS HOSPITALIZED FOR HIGH WITH BLOOD GLUCOSE OVER 1500 MG/DL AT TIME OF ADMISSION. THE FIRST TIME WAS WHEN HIS WIFE PASSED AWAY. HE WAS NOT PAYING ATTENTION AND CRASHED THE CAR AND WENT INTO A COMA. THEN CUSTOMER'S HOUSE WAS BURGLARIZED. FIRST HOSPITALIZATION FOR BLOOD SUGAR RELATED (B)(6) 2016. THAT IS WHEN CUSTOMER CRASHED THE CAR. CUSTOMER DOES NOT KNOW WHAT IT WAS. HE JUST WAS NOT PAYING ATTENTION BECAUSE HIS WIFE DIED AND HE WAS MORE CONCERNED ABOUT THAT. THEN CUSTOMER ALSO HAD 9 HEART ATTACKS. CUSTOMER IS CURRENTLY ON PEN AND HAS TO EAT CONSTANTLY TO KEEP BLOOD GLUCOSE UP. CUSTOMER WEARING THE PUMP AT TIME OF HOSPITALIZATION. CUSTOMER HAD 5 STROKES WHILE IN HOSPITAL. CUSTOMER WAS IN HOSPITAL FOR A MONTH. HE WAS TREATED FOR LOW BLOOD GLUCOSE AND HIGH BLOOD GLUCOSE. CUSTOMER STATED HE WAS IN THE HOSPITAL (B)(6) 2017 FOR A LOW BLOOD GLUCOSE OF 22 MG/DL BUT WAS NOT WEARING THE PUMP AT THE TIME AND WAS ON INJECTIONS. HE STATED HE HAS A HARD TIME WHILE ON INJECTIONS MAINTAINING BL

  Patient problems: Hyperglycemia

  MAUDE report 7004415 ↗
• InjuryOct 31, 2017Insufficient Device Problem Information

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH UNKNOWN BLOOD GLUCOSE AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 169 M/DL AT THE TIME OF THE CALL. THE CUSTOMER ALSO STATED THAT THEY WERE AT THE HOSPITAL ON (B)(6) 2017 FOR A LOW OF 22 MG/DL, BUT THEY WERE USING MANUAL INJECTIONS AT THE TIME. THE CUSTOMER ADDED THAT THEY HAVE A HARD TIME CONTROLLING THEIR BLOOD GLUCOSE WHILE ON INJECTIONS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE PREVIOUS INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER HAD 5 STROKES WHILE HOSPITALIZED. THE CUSTOMER ALSO REPORTED OTHER HOSPITALIZATIONS FOR HIGHS AND LOWS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6992200 ↗
• InjuryOct 31, 2017Device Operates Differently Than Expected

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ISSUES ON (B)(6) 2016 WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 169 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER CRASHED THE CAR DUE TO LOW BLOOD GLUCOSE AFTER HIS WIFE PASSED AWAY. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS CONFUSION AND GOING INTO A COMA. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THIS WAS A PAST INCIDENT THE CUSTOMER HAS BEEN IN AND OUT OF THE HOSPITAL 30 TIMES IN THE LAST YEAR AND A HALF, AND HAS HAD 9 HEART ATTACKS. CUSTOMER IS USING INSULIN PENS CURRENTLY AS THEY LOST THEIR SERTER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Coma; Hypoglycemia

  MAUDE report 6992131 ↗
• InjuryJun 8, 2017Battery Problem; Device Handling Problem

  THE CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON (B)(6) 2017 WITH A BLOOD GLUCOSE LEVEL OF 686 MG/DL. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS VOMITING AND FEELING DISORIENTED. THE CUSTOMER WAS TREATED WITH INSULIN DRIP AND INJECTIONS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. THE CUSTOMER WAS ASSISTED WITH CLEARING A BATTERY OUT LIMIT ALARM. THE BATTERIES WERE OUT OF THE INSULIN PUMP GREATER THAN DURATION ALLOWED BY THE INSULIN PUMP. THE INSULIN PUMP WAS WORKING AS DESIGNED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6622370 ↗

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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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