PARADIGM® REAL-time MMT-522NAS (UDI 00613994622655)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00613994622655), received between Jun 28, 2017 and May 14, 2020 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2020Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem; Obstruction of Flow; Material Integrity Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALARM AND BATTERY CAP THREADING WAS CAME OFF IN SOME OF THE AREAS AROUND IT. 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 10054790 ↗
• MalfunctionDec 30, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER¿S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY WERE UNABLE TO CLEAR THE ALARM. CUSTOMER WAS NOT ABLE TO COMPLETE REWIND. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED 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 9529812 ↗
• MalfunctionDec 4, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPLAINED MOTOR ERROR AND UNRESPONSIVE BUTTONS. 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 9409530 ↗
• MalfunctionNov 27, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT BUTTONS WERE HARD TO PRESS AND RECEIVED MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE BUTTONS LESS RESPONSIVE AND NO DELIVERY ALERTS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9381671 ↗
• MalfunctionSep 17, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD RANDOM NO DELIVERY ALARMS AND BATTERY CAP HAD A CHIP ON THE TOP CORNER. THE CUSTOMER STATED THAT BUTTONS OF INSULIN PUMP WAS STICK WHEN PRESSED AND UNRESPONSIVE. CUSTOMER STATED THAT SOMETIMES REWIND TOOK LONGER. CUSTOMER ALSO STATED THAT INSULIN PUMP HAD BEEN NON-RESPONSIVE TO A NEW BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9074973 ↗
• MalfunctionApr 23, 2019Failure 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 140 MG/DL AT THE TIME OF THE INCIDENT. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8538716 ↗
• InjuryMar 18, 2019Device Alarm System; Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD ABSENCE OF OCCLUSION ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 355 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8429556 ↗
• MalfunctionFeb 26, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE CRACKS IN THE INSULIN PUMP BODY AND SCREEN WAS CRACKED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS OVER 200MG/DL AT THE TIME OF THE INCIDENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369249 ↗
• MalfunctionFeb 15, 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 ACT BUTTON WAS NOT ALWAYS RESPONSIVE AND ALSO HAD LOW BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8342260 ↗
• InjuryNov 5, 2018No Apparent Adverse Event; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCE THE HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE RANGE OF 400 MG/DL. AT THE TIME OF INCIDENT. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 317 MG/DL. CUSTOMER¿S ALSO EXPERIENCED BLOOD GLUCOSE AROUND 500 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. 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: Hyperglycemia

  MAUDE report 8039833 ↗
• MalfunctionOct 8, 2018Failure 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 110 MG/DL 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 TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7942161 ↗
• MalfunctionOct 2, 2018Patient Device Interaction Problem; 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 BUTTON WASN'T WORKING ON THE PUMP. THE CUSTOMER REPORTED THAT THEY HAD DAMAGE ON THE SCREEN AND WAS NOT ABLE TO READ THE PUMP. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7928984 ↗
• InjuryJul 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AT THE LEVEL OF 471 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP. CUSTOMER REPORTED LEAKS. TROUBLESHOOTING WAS COMPLETED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7662085 ↗
• InjuryJun 27, 2018Obstruction of Flow; Device Displays Incorrect Message; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT NO DELIVERY ALARM WAS OCCURRED. BLOOD GLUCOSE WAS 305 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7640711 ↗
• MalfunctionJun 5, 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 150 MG/DL AT THE TIME OF THE INCIDENT. 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 7570784 ↗
• InjuryJun 1, 2018Device Displays Incorrect Message; Reset Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 410 MG/DL AT THE TIME OF THE INCIDENT, DECLINED TO TROUBLE SHOOT FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER STATES THEY WOKE UP WITH HIGH BLOOD GLUCOSE LEVELS, TREATED WITH MANUAL INJECTION. THE CUSTOMER STATED THAT THE INSULIN PUMP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS NOT ABLE TO COMPLETE THE REWIND PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7559961 ↗
• MalfunctionMar 7, 2018Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP GOT DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE WAS 208 MG/DL. THE CUSTOMER STATED THAT OPENING OF THE RESERVOIR COMPARTMENT WAS DAMAGED. 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 7321094 ↗
• MalfunctionFeb 9, 2018No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. 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 7261190 ↗
• MalfunctionFeb 7, 2018No Display/Image

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER¿S BLOOD GLUCOSE WAS 195MG/DL AT TIME OF INCIDENT. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7249491 ↗
• MalfunctionSep 18, 2017Fluid/Blood Leak; Device Displays Incorrect Message

  THE CUSTOMER CALLED VIA PHONE CALL THAT HIS PUMP ALARMED COMPROMISED FORCED SENSOR. AT THE TIME OF THE INCIDENT, HIS BLOOD GLUCOSE 168 MG/DL. THE CUSTOMER SAID THAT HE WAS IN THE MIDDLE OF TRYING TO CHANGE HIS INFUSION SET WHEN THE ALARM OCCURRED AND THAT HE IS STUCK IN PREPARING PRIME LOOP. DURING PRIME REWIND TROUBLESHOOTING, THE CUSTOMER SAID THAT INSULIN WAS SQUIRTING OUT AND CONTINUED TO DRIP AFTER THE MOTOR STOPPED DURING THE MANUAL PRIME PROCESS. HE SAID THAT THE PUMP IS ALARMING COMPROMISED FORCED SENSOR AND THAT THEY ARE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. HE SAID THAT HE IS STUCK IN REWIND COMPLETE/BOLUS DELIVERY LOOP. THE CUSTOMER WAS ADVISED TO HOLD THE ACT BUTTON DOWN UNTIL HE RECEIVED THE 2ND SERIES OF BEEPS AND/OR NUMBERS APPEARED ON HIS DISPLAY. HE SAID THAT NOTHING HAPPENED WHEN HE HELD THE BUTTON DOWN. THE COMPROMISED FORCED SENSOR ALARM RECURRED. HE WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN PER HIS DOCTOR¿S ORDERS. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6872936 ↗
• MalfunctionSep 1, 2017Device 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. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING REWIND/PRIME PROCESS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6838183 ↗
• MalfunctionAug 8, 2017No Display/Image; Moisture Damage; Device Inoperable; Noise, Audible

  CUSTOMER REPORTED VIA PHONE CALL MOISTURE DAMAGE AND PARTIAL DISPLAY ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING FOR MOISTURE DAMAGE WAS PERFORMED. CUSTOMER ADVISED THEY WENT INTO THE SWIMMING POOL WHILE WEARING THE INSULIN PUMP. CUSTOMER ADVISED THE INSULIN PUMP DID NOT WORK, THERE WERE BLACK STREAKS AT THE TOP OF THE LCD DISPLAY SCREEN AND THE DEVICE HAD A BUZZING NOISE. 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 6774283 ↗
• MalfunctionJun 28, 2017Moisture Damage; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BUTTON ERROR ALARM AFTER BEING EXPOSED TO WATER. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 196 MG/DL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6673866 ↗

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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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-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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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