PARADIGM® REAL-time MMT-722LNAPRecalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 00613994409546), received between Jun 2, 2017 and Sep 23, 2020 — classified as 39 injuries, 79 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (25 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 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2020Obstruction of Flow; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND INSULIN WAS EXITED. CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10571509 ↗
• MalfunctionJul 2, 2020Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NON RESPONSIVE. INSULIN PUMP HAD BLOTCHY BLURRY SCREEN, REJECT NEW BATTERIES, RESERVOIR ERROR. 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 10222737 ↗
• MalfunctionJun 26, 2020No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BLANK SCREEN, HAD BUTTON ISSUE. THE CUSTOMER REPORTED THAT INSULIN PUMP WAS NOT WORKING PROPERLY. 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 10199594 ↗
• MalfunctionMay 26, 2020Computer Software Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Computer Software Problem; Mechanical Problem; Obstruction of Flow; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP SHOOT OUT INSULIN DURING PRIMING, MOTOR ERROR, UNEXPLAINED ERROR. CUSTOMER STATED INSULIN PUMP HAD REJECTED NEW BATTERIES, LOUD DURING REWIND, NO DELIVERY ALARM, LOST SETTING DURING BATTERY CHANGE. 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 10086154 ↗
• InjuryApr 22, 2020Mechanical Problem; No Apparent Adverse Event; Mechanical Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 451 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR AND MOTOR ERROR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9986634 ↗
• InjuryApr 10, 2020No Apparent Adverse Event; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 557 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9950821 ↗
• MalfunctionApr 8, 2020Mechanical Problem; Obstruction of Flow; Mechanical Problem; Obstruction of Flow

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED A MOTOR ERROR AND NO DELIVERY ALARM. 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 9937035 ↗
• MalfunctionFeb 28, 2020Device Alarm System; Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Alarm System; Display or Visual Feedback Problem; Obstruction of Flow; Power Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD INSULIN PUMP ERROR ALARM. CUSTOMER STATED THAT INSULIN PUMP HAD CRACKS AND HAD BLOTCHES ON SCREEN. CUSTOMER STATED THAT INSULIN PUMP HAD REJECTED NEW BATTERIES AND GAVE UNEXPLAINED RANDOM NO DELIVERY ALARM. CUSTOMER STATED THAT THEY EXPERIENCED GRINDING NOISE DURING REWIND. CUSTOMER STATED THEY LOST INSULIN PUMP SETTINGS ALSO REWOUND TOOK LONGER. CUSTOMER REPORTED ALARM WAS NOT AUDIBLE AND SCREEN LOST SOME BRIGHTNESS. CUSTOMER REPORTED HAD BEEN OFF INSULIN PUMP FOR 4 YEARS. 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 9768292 ↗
• MalfunctionFeb 27, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. 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 9762512 ↗
• InjuryJan 27, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE LEVELS IN THE 30 MG/DL RANGE AT THE TIME OF THE INCIDENT. THE CUSTOMER USED FOOD AND WAS GIVEN GLUCOSE TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THEIR PUMP DRIVE SUPPORT CAP WAS PROTRUDED. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS ON A DIFFERENT CASE.

  Patient problems: Hypoglycemia

  MAUDE report 9630768 ↗
• MalfunctionJan 23, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER STATED THAT THEY GOT A BATTERY OUT LIMIT AFTER CHANGING A BATTERY DUE TO BUTTONS WERE NOT WORKING AND ALL BUTTONS WERE NOT WORKING AND DEVICE WAS BEEPING. 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 9620164 ↗
• InjuryJan 20, 2020Failure to Cycle; Detachment of Device or Device Component; No Apparent Adverse Event; Failure to Cycle; Detachment of Device or Device Component; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AND 473 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION OF 20 UNITS. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. TROUBLESHOOTING WAS PERFORMED FOR INSULIN PUMP ERROR ALARM. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED, TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9609329 ↗
• MalfunctionJan 13, 2020Failure 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 UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THEY GOT INSULIN PUMP ERROR ALARM THEY TRIED TO REWINDING THE INSULIN PUMP AND SHE RECEIVED THE AGAIN INSULIN PUMP ERROR ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 9580023 ↗
• MalfunctionDec 31, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR AND BUTTONS DID NOT WORK AT ALL. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER DECLINED TO REPORT TO 24 HOURS TECHNICAL SUPPORT TEAM. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9534625 ↗
• MalfunctionDec 23, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP BUTTONS WERE DIFFICULT TO PRESS. CUSTOMER¿S BLOOD GLUCOSE 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 9509877 ↗
• MalfunctionDec 13, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP REWIND WAS NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT DRIVE SUPPORT WAS STICKING OUT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN PER HEALTH CARE PROFESSIONAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465354 ↗
• MalfunctionNov 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ANOMALY. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 265 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS IN POCKET AND STARTED TO ALARM BUTTON ERROR. CUSTOMER WAS ADVISED TO OBSERVE THE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME WAS ADVANCE. CUSTOMER WAS ADVICE TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REVERT THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL. THE DEVICE WILL NOT RETURN FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346052 ↗
• MalfunctionNov 14, 2019Battery Problem; No Apparent Adverse Event; Battery Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP BATTERY GIVES OUT. 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: Hyperglycemia

  MAUDE report 9321716 ↗
• MalfunctionSep 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC LEGAL RECEIVED INFORMATION REGARDING UNKNOWN ISSUE WITH THE INSULIN PUMP FROM THE ATTORNEY OF THE FAMILY. THE INFORMATION WAS RECEIVED ON (B)(6) 2019. CUSTOMER WAS USING THE MEDTRONIC MINIMED. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9133041 ↗
• MalfunctionSep 20, 2019Battery Problem; Power Problem; Insufficient Device Problem Information; Battery Problem; Power Problem; Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNSPECIFIED ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD DIMINISHED BATTERY LIFE AND ALSO REJECTED NEW BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9096417 ↗
• MalfunctionSep 13, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM WHILE CHANGING THE INFUSION SET. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 145 MG/DL. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9035955 ↗
• MalfunctionJul 31, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 162 MG/DL. CUSTOMER ALSO STATED THAT THEY WILL CLEAR OFF THE BUTTON ERROR. IT WAS ALSO STATED THAT THE INSULIN PUMP TIME ADVANCES. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844718 ↗
• MalfunctionJul 26, 2019Device Difficult to Program or Calibrate; Visual Prompts will not Clear; Device Difficult to Program or Calibrate; Visual Prompts will not Clear

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 22 MG/DL. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS NOT ADVANCED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830106 ↗
• MalfunctionJul 18, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available; Mechanical Problem; Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 MG/DL. THE KEYS WERE NOT RESPONDING. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER WAS ABLE TO COMPLETE INSULIN PUMP REWIND. THE TROUBLESHOOTING WAS PERFORMED FOR THE MOTOR ERROR AND BUTTON ERROR. THE CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND FOUND YES. ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801437 ↗
• InjuryJul 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 526 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED BLOOD GLUCOSE GOING HIGH DURING THE DAY AND THEN LOW AT NIGHT. CUSTOMER DID NOT PROVIDE FURTHER DETAILS RELATED TO HIGH BLOOD GLUCOSE EVENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8793066 ↗

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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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