PARADIGM® REAL-time MMT-722NAH (UDI 00613994622587)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00613994622587), received between Jun 6, 2017 and Jan 15, 2020 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (9 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.

• MalfunctionJan 15, 2020Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER ALSO REPORTED THAT THEY WERE UNABLE TO REWIND INSULIN PUMP. 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 9590039 ↗
• MalfunctionJan 11, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS ABLE TO REWIND. DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER STATED THAT THE TOP PART GOING TO SCREEN WAS CRACKED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9579081 ↗
• MalfunctionSep 20, 2019Device Displays Incorrect Message

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AND HE CANNOT CLEAR THE ALARM BY PRESSING ECT+ ACT. THE CUSTOMER MENTION THE PUMP WAS NOT BUMPED, DROPPED OR EXPOSED TO MOISTURE. NO FURTHER DETAILS ARE GIVEN. PUMP WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9097033 ↗
• InjuryMay 21, 2019Insufficient Flow or Under Infusion; Obstruction of Flow; Material Integrity Problem; Insufficient Flow or Under Infusion; Obstruction of Flow; Material Integrity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT HOSPITAL DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON UNKNOWN DATE. CUSTOMER¿S BLOOD GLUCOSE WAS 446 MG/DL IN THE HOSPITAL. CUSTOMER HAD BLOOD GLUCOSE OF 40 TO 100. CUSTOMER HAD SYMPTOMS SUCH AS NAUSEA, VOMITING ABDOMINAL PAIN, DIFFICULTY BREATHING. CUSTOMER WAS TREATED THAT WITH INSULIN DRIP. CUSTOMER STATED THAT THE BUTTONS WERE HARD TO PUSH. INSULIN PUMP WAS SCRATCHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Hypoglycemia

  MAUDE report 8626791 ↗
• MalfunctionFeb 15, 2019Premature Discharge of Battery; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Device Difficult to Program or Calibrate; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT HER SON INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE LESS RESPONSIVE AND FAILED BATTERY. IT WAS REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8342243 ↗
• MalfunctionJan 16, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 128 MG/DL. THE CUSTOMER STATED THAT DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NO LONGER WORKING. TROUBLESHOOTING WAS PERFORMED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252161 ↗
• MalfunctionJan 8, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; 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 8225351 ↗
• MalfunctionOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 580 MG/DL ON MARCH 30, 2018. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 180 MG/DL. THE CUSTOMER'S PARENT DID NOT REPORT ANY SYMPTOMS BUT WAS TREATED WITH THE INSULIN PUMP. THE CUSTOMER'S PARENT STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WOULD NOT GO DOWN DURING THE NIGHT, BUT THAT THIS WAS ABLE TO BE RESOLVED BY CHANGING THE INFUSION SITE. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE AS IT HAD ALREADY BEEN RESOLVED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7954495 ↗
• MalfunctionOct 10, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON NOT RESPONDING. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 137 MG/DL. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7951013 ↗
• MalfunctionOct 1, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON ERROR. THE PATIENT¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE 147 MG/DL. 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 7924732 ↗
• MalfunctionJun 26, 2018Device Inoperable

  THE CUSTOMER REPORTED VIA CALL THAT THE INSULIN PUMP WAS NOT WORKING. 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 7636819 ↗
• InjuryApr 9, 2018Device Inoperable

  IT WAS REPORTED THAT CUSTOMER RECONNECTED TO INSULIN PUMP AFTER TWO YEARS AND BELIEVED INSULIN PUMP WAS NOT LONGER WORKING DUE TO EXPERIENCING HIGH BLOOD GLUCOSE LEVELS OF 419 MG/DL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 328 MG/DL. CUSTOMER STATES DRIVE SUPPORT CAP IS NORMAL. IT WAS REPORTED THAT THE CLINICAL SPECIALIST WOULD ASSIST CUSTOMER. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7410238 ↗
• InjuryDec 28, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 286 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER RECEIVED MOTOR ERROR THEN COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7153416 ↗
• MalfunctionDec 14, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED FOR COMPROMISED FORCE SENSOR SYSTEM. TROUBLESHOOTING WAS PERFORMED FOR THE ALERT. CUSTOMER¿S BLOOD GLUCOSE WAS 250 MG/DL AT TIME OF INCIDENT. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7119961 ↗
• MalfunctionDec 7, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS UNKNOWN. THE DRIVE SUPPORT CAP WAS NORMAL. 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 7096371 ↗
• MalfunctionNov 1, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 233 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6993536 ↗
• MalfunctionOct 26, 2017Visual Prompts will not Clear; Device Displays Incorrect Message; Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A FAILED BATTERY TEST AND UNABLE TO CLEAR THE ALARM. CUSTOMER¿S BLOOD GLUCOSE WAS 136 MG/DL AT THE TIME OF INCIDENT. CUSTOMER ALSO REPORTED TO HAVE RECEIVED A CALIBRATION ERROR ALARM. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6981866 ↗
• MalfunctionJul 19, 2017Device Inoperable

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ALARMED UNEXPECTED RESTART AND WAS UNABLE TO CLEAR IT DUE TO UNRESPONSIVE BUTTONS. TROUBLESHOOTING FOR BUTTON ERROR/KEYPAD ANOMALY WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO STATED THAT THERE WAS NO SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUES. THE CUSTOMER STATED THAT THE TIME ON THE CLOCK ADVANCED WHEN MONITORED FOR ONE MINUTE. 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. TROUBLESHOOTING FOR UNEXPECTED RESTART WAS PERFORMED. THE CUSTOMER REPORTED THAT THERE WAS NO TEMP BASAL PROGRAMMED PRIOR TO THE UNEXPECTED RESTART ALARM. THE CUSTOMER REPORTED THAT INSULIN PUMP WAS NOT STORED OR NOT IN USED FOR AN EXTENDED PERIOD OF TIME. THE CUSTOMER ALSO STATED THE ALARM DID NOT OCCUR SHORTLY DURING BATTERY CHANGE BUT ALARM WAS RECURRING DURING NORMAL USE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6726416 ↗
• MalfunctionJul 19, 2017Device Displays Incorrect Message

  IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP ALARMED AND WAS UNABLE TO CLEAR. TROUBLESHOOTING WAS NOT COMPLETED. THE CUSTOMER'S BLOOD SUGAR IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726319 ↗
• MalfunctionJun 19, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING THE REWIND/PRIME SEQUENCE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 389 MG/DL. 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: Hyperglycemia

  MAUDE report 6652524 ↗
• MalfunctionJun 8, 2017Device Alarm System

  CUSTOMER REPORTED VIA PHONE CALL COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 238 MG/DL. TROUBLESHOOTING FOR THE PRIME REWIND WAS PERFORMED. CUSTOMER ADVISED DURING THE SEATING OF THE FORCE THE SENSOR DID NOT DETECT THE RESERVOIR. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. 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 6623767 ↗
• MalfunctionJun 6, 2017Loose or Intermittent Connection; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. IT WAS ALSO MENTIONED THAT THE DRIVE SUPPORT CAP WAS LOOSE. BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. NO FURTHER DETAILS WERE PROVIDED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6616423 ↗

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-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-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-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-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