PARADIGM® REAL-time MMT-722NAB (UDI 00885074419800)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00885074419800), received between Jun 3, 2017 and Jul 21, 2020 — classified as 1 death, 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2020Adverse 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) 2020 WITH BLOOD GLUCOSE OF 424 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED THE PUMP TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER DETAILS ON THE INCIDENT WERE PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10305048 ↗
• InjuryJul 21, 2020Adverse 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) 2020 WITH BLOOD GLUCOSE OF 524 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED THE PUMP TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AND NO FURTHER DETAILS ABOUT THE INCIDENT WERE PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10305042 ↗
• InjuryJul 2, 2020Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2020 WITH BLOOD GLUCOSE OF OVER 600 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN DRIP. CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 10222809 ↗
• MalfunctionMar 17, 2020Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE COMPROMISED FORCED SENSOR SYSTEM ERROR ALARMS ON THE INSULIN PUMP EVEN AFTER CHANGING THE RESERVOIR. THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 9841289 ↗
• MalfunctionJan 10, 2020Application Program Version or Upgrade Problem; Loss of Data; Adverse Event Without Identified Device or Use Problem; Application Program Version or Upgrade Problem; Loss of Data; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD FAILURE OF FLASH MEMORY ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT REQUIRE REWIND. CUSTOMER ALSO STATED THAT THE INSULIN PUMP HAD NEW SOFTWARE RELEASE DETECTED ALERT SECOND TIME AFTER CLEARING THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9573965 ↗
• MalfunctionJul 18, 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 CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE STICKY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8801414 ↗
• MalfunctionJul 4, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS UNABLE TO COMPLETE REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762580 ↗
• MalfunctionJun 4, 2019Premature Discharge of Battery; Power Problem; Unexpected Shutdown; Premature Discharge of Battery; Power Problem; Unexpected Shutdown

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MULTIPLE PUMP ERRORS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS NOT PERFORMED FOR PUMP ERROR. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667697 ↗
• MalfunctionMar 7, 2019Premature Discharge of Battery; Display or Visual Feedback Problem; Mechanical Problem; Power Problem; Premature Discharge of Battery; Display or Visual Feedback Problem; Mechanical Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART AND SCREEN WAS HARD TO READ. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECT NEW BATTERIES GRINDING WHILE REWINDING AND THE INSULIN PUMP LOST DATE AND TIME SETTING. 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 8398228 ↗
• MalfunctionOct 30, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD A MOTOR ERROR AND INSULIN PUMP REJECTING THE NEW BATTERIES. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8022132 ↗
• MalfunctionAug 30, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  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 STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7831798 ↗
• MalfunctionAug 16, 2018Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. BLOOD GLUCOSE WAS AT THE LEVEL OF 80 MG/DL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROVIDER'S INSTRUCTION. THE CUSTOMER WILL RECEIVE A REPLACEMENT INSULIN PUMP AND WILL RETURN THE ONE THEY CURRENTLY USE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7791916 ↗
• InjuryAug 14, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE INSULIN PUMP GOT NO DELIVERY ALARM DURING PRIME. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 485 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Reaction, Injection Site

  MAUDE report 7783535 ↗
• MalfunctionJul 19, 2018Power Problem; Power Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BATTERY OUT LIMIT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. THE BUTTONS WERE UNRESPONSIVE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7702085 ↗
• MalfunctionMay 1, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY AND UNEXPECTED RESTART ALARM THE CUSTOMER¿S BLOOD GLUCOSE WAS 106 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART ALARM AND UNABLE TO CLEAR IT. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476230 ↗
• MalfunctionMar 13, 2018Inappropriate or Unexpected Reset

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 160MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTHCARE PROFESSIONAL¿S INSTRUCTION. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS AND A REPLACEMENT PUMP WILL BE SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333329 ↗
• MalfunctionMar 13, 2018Device Displays Incorrect Message; Inappropriate or Unexpected Reset

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 160MG/DL. CUSTOMER STATED THAT THE ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER WAS ADVISED TO CONTINUE TO WEAR THE PUMP UNTIL REPLACEMENT ARRIVES. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333326 ↗
• DeathFeb 22, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY IN AN UNKNOWN LOCATION. THE CAUSE OF DEATH WAS INJURIES FROM BEING STRUCK BY A VEHICLE. THE CALLER STATED THAT THE CUSTOMER HAD NO 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 CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 7290287 ↗
• MalfunctionAug 29, 2017Fluid/Blood Leak; Failure to Select Signal; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ALARMED COMPROMISED FORCED SENSOR SYSTEM DURING PRIME FILL PROCESS. CUSTOMER STATED THAT INSULIN IS SQUIRTING OUT OF THE INSULIN PUMP. CUSTOMER REPORTED THAT THE FORCE SENSOR DOES NOT DETECT THE RESERVOIR. CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 300 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 279 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: Hyperglycemia

  MAUDE report 6828682 ↗
• InjuryAug 21, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 568 MG/DL. THE CUSTOMER STATED THE INSULIN PUMP ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARED NORMAL. THERE MAY HAVE BEEN SITE RELATED ISSUES OR OCCLUSION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6808431 ↗
• InjuryJun 9, 2017Excess Flow or Over-Infusion; Improper or Incorrect Procedure or Method; Material Protrusion/Extrusion

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017, WITH BLOOD GLUCOSE OF 32 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS PRIMING THE PUMP WHILE CONNECTED AND GAVE HIMSELF TOO MUCH INSULIN. THE CUSTOMER WAS GIVEN GLUCOSE TABLETS TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS AND STROKE. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP DURING THE INCIDENT WITHIN LESS THAN 48 HOURS. TROUBLESHOOTING WAS NOT COMPLETED. CUSTOMER HAD CALLED EARLIER WITH A COMPROMISED FORCE SENSOR ALARM AND A DRIVE SUPPORT CAP THAT WAS STICKING OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6630085 ↗
• MalfunctionJun 3, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM THE CUSTOMER DID NOT PROVIDE THEIR BLOOD GLUCOSE VALUE AT THE TIME OF THE INCIDENT THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. 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 6610295 ↗

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-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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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