PARADIGM® REAL-time MMT-722RNAS (UDI 00613994409157)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994409157), received between Jun 29, 2017 and May 20, 2020 — classified as 5 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD SCRATCHES AND WOULD MAKE IT HARD TO READ THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER BELIEVES SCRATCHES APPEARED FROM WEARING IT IN HIS POCKET WITH KEYS OR COINS IN HIS POCKET. THE CUSTOMER AS 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 10073907 ↗
• MalfunctionJan 14, 2020Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM WHEN THEY REFILL THE INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 137 MG/DL. THE CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT REQUIRED REWIND. 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: No Consequences Or Impact To Patient

  MAUDE report 9584737 ↗
• MalfunctionNov 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 HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. CUSTOMER STATES THEY WERE STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 9294184 ↗
• MalfunctionSep 11, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE THAT THE BUTTONS WERE STICKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THEY WERE NOT ABLE TO STOP INSULIN DELIVERY DUE TO STUCK BUTTON. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8987449 ↗
• MalfunctionJul 24, 2019Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP DID NOT VIBRATE ON SHUTTING OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER ALSO REPORTED NO LOW RESERVOIR ALARM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8821207 ↗
• InjuryMay 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AS WELL AS HYPERGLYCEMIA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 417 MG/DL AT THE TIME OF INCIDENT AND TREATED WITH MANUAL INJECTION AND CURRENT BLOOD GLUCOSE LEVEL WAS 61 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTS THEY HAVE CONTACTED THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE. CUSTOMER DID NOT ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER DECLINED TO CHECK THEIR SETTINGS. CUSTOMER DECLINED LOW BLOOD GLUCOSE TROUBLESHOOTING. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8623221 ↗
• MalfunctionMay 2, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT SCREEN WAS SCRATCHED AND UNABLE TO READ CLEARLY. BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ALSO REPORTED THAT RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 8572429 ↗
• MalfunctionDec 20, 2018Failure to Cycle; Mechanical Problem; Device Difficult to Program or Calibrate; Failure to Cycle; Mechanical Problem; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR AND KEYPAD UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATES INSULIN WAS SQUIRT OUT FROM INFUSION SET. CUSTOMER STATES INSULIN PUMP HAD SCRATCHES ON DISPLAY AND IT AFFECTS ABILITY TO READ ON SCREEN. CUSTOMER REPORTED THAT THE RESERVOIR PLASTIC PIECE WAS CHIPPED OFF. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8183571 ↗
• MalfunctionSep 13, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRING OUT DURING MANUAL PRIME PROCESS. THE BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7873618 ↗
• MalfunctionSep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT DRIVE SUPPORT CAP WAS FLUSHED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 265 MG/DL AT THE TIME OF THE INCIDENT. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7842779 ↗
• InjuryDec 1, 2017False Reading From Device Non-Compliance; Kinked; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL AND THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 430 MG/DL, AT THE TIME OF INCIDENT 200 MG/DL AND CURRENT BLOOD GLUCOSE LEVEL WAS 143 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NO LONGER FUNCTIONING AND THE INSULIN PUMP WAS GIVING IRREGULAR READINGS. THE CUSTOMER ALLEGED INSULIN PUMP WAS UNDER DELIVERING AS THE CUSTOMER WAS GIVING INSULIN CORRECTION. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL AND CANNULA WAS SLIGHT KINKED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7077247 ↗
• InjuryOct 17, 2017No Display/Image; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR, NO DELIVERY, MOTOR ERROR, AND A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER ALSO REPORTED TO HAVE EXPERIENCED A HIGH BLOOD GLUCOSE OF 400 MG/DL TO 500 MG/DL AND TREATED WITH MANUAL INJECTION AND INSULIN PUMP. CUSTOMER DECLINED TROUBLESHOOTING ON ALL INSULIN PUMP ISSUES. TTHE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6956293 ↗
• InjuryOct 16, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 38 MG/DL. THE CALLER ALSO REPORTED LOW BATTERY. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS OF THEIR BLOOD GLUCOSE LEVELS. THE CUSTOMER MENTIONED EATING CARBOHYDRATES AND GLUCOSE TABLETS AS TREATMENT FOR THEIR BLOOD GLUCOSE LEVELS. THE CUSTOMER DID NOT TROUBLESHOOT THE ISSUE AT THE TIME OF THE CALL. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6951425 ↗
• InjuryOct 9, 2017Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 587 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. CUSTOMER WILL NOT RETURN DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6930194 ↗
• MalfunctionOct 3, 2017Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 274 MG/DL .TROUBLESHOOTING WAS PERFORMED FOR UNEXPECTED RESTART AND RECEIVING ANOTHER UNEXPECTED RESTART ALARM AFTER A BATTERY CHANGE. ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ALSO ADVISED THEY MAY CONTINUE TO WEAR PUMP UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6912894 ↗
• MalfunctionAug 19, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A MOTOR ENCODER POSITION ERROR. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 170 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. 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 6806303 ↗
• MalfunctionAug 10, 2017Device Displays Incorrect Message; Inappropriate or Unexpected Reset; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 179 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED FAILED BATTERY TEST, BATTERY OUT LIMIT, AND UNEXPECTED RESTART. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. 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 6786496 ↗
• MalfunctionJul 25, 2017Display or Visual Feedback Problem; Looping

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME SCREEN. CUSTOMER CANNOT RECALL BLOOD GLUCOSE READING. CUSTOMER STATED THE INSULIN PUMP WAS NOT ABLE TO EXIT THE LOOP WHILE CHANGING THE SET. THE CUSTOMER STATED THAT THEY DID NOT RECEIVE THE BEEPS NOR DID THE NUMBERS APPEAR ON THE SCREEN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTHCARE PROVIDER INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6740632 ↗
• MalfunctionJun 29, 2017Break; Device 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 134 MG/DL AT THE TIME OF THE INCIDENT. DEVICE BOTTOM WAS BROKEN. 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 6679236 ↗

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-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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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