PARADIGM® REAL-time MMT-522NAB (UDI 00613994402127)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00613994402127), received between Jun 22, 2017 and May 18, 2020 — classified as 3 injuries, 17 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON INSULIN PUMP WERE HARD TO PRESS. THE CUSTOMER STATED THAT HE WAS TRYING TO PRIME, HE HAS TO PRESS THE ACT BUTTON A COUPLE OF TIMES TO GET IT TO WORK, IT WILL BEEP A COUPLE OF TIMES. 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 10064744 ↗
• MalfunctionDec 24, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  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 THEY HAD TO PRESS BUTTONS A COUPLE OF TIMES TO GET IT TO WORK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9515893 ↗
• MalfunctionDec 17, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR FUNCTION ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE BATTERY COMPARTMENT WAS CRACKED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9480402 ↗
• MalfunctionAug 26, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS 212 MG/DL. THE BUTTONS WERE NOT RESPONDING. THE TIME CLOCK WAS ADVANCES. THE CUSTOMER WAS ADVISED THAT THE PUMP WILL NEED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8929758 ↗
• MalfunctionJul 25, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ARROW UP BUTTON OF INSULIN PUMP WAS NOT WORKING AND WHEN THEY PRESS IT, IT DID NOT REGISTER ANYTHING. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 128 MG/DL. BASED ON TROUBLESHOOTING 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 8826159 ↗
• MalfunctionApr 15, 2019Display or Visual Feedback Problem; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SHOWING LINES ALL OVER AND SHE CANNOT READ ANYTHING ON THE PUMP WHEN SHE PRESS THE BUTTON THIS MORNING. THE CUSTOMER¿S BLOOD GLUCOSE WAS 126 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8513670 ↗
• InjuryMar 29, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; 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) 2019 WITH BLOOD GLUCOSE OF 458 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 361 MG/DL. THE CUSTOMER WAS REPORTED OTHER BLOOD GLUCOSE VALUE SUCH 468 MG/DL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS, SALINE IN THE HOSPITAL AND MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR BENT CANNULA. CUSTOMER WAS REPORTED THAT THEY WERE UNABLE TO COMPLETE CARE LINK UPLOAD. THE CUSTOMER WAS DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8463235 ↗
• InjuryNov 21, 2018Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem; Mechanical Problem; Detachment of Device or Device Component; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 475 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8098142 ↗
• MalfunctionOct 12, 2018Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  THE CUSTOMER CALLED AND REPORTED THAT THEIR INSULIN PUMP HAD A STUCK UP ARROW BUTTON, HAD PHYSICAL DAMAGE, AND WAS OVER DELIVERING INSULIN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THE BATTERY HOUSING WAS BROKEN AND WAS TAPED TOGETHER IN ADDITION TO A CRACK ON THE RESERVOIR CHAMBER. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7959205 ↗
• MalfunctionOct 8, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT PIECE IS BROKEN OFF. 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 7942869 ↗
• MalfunctionJul 13, 2018Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP REJECTED NEW BATTERIES. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO STATED THAT THE WHEN CHANGING INFUSION SET REWIND SEEMS TO TAKE LONGER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7686935 ↗
• MalfunctionFeb 24, 2018Loose or Intermittent Connection; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR DURING INFUSION SET CHANGE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 226 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE. 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: No Consequences Or Impact To Patient

  MAUDE report 7294539 ↗
• MalfunctionJan 4, 2018Device Displays Incorrect Message; Device Operational Issue; Material Protrusion/Extrusion

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALERT WITH PRIME REWIND ANOMALY. THE BLOOD GLUCOSE WAS 130 MG/DL AT THE TIME OF THE INCIDENT. THE DRIVE SUPPORT CAP IS STICKING OUT. CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACK UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7166520 ↗
• MalfunctionDec 11, 2017Loose or Intermittent Connection

  CUSTOMER REPORTED VIA PHONE CALL THAT THE DRIVE SUPPORT CAP WAS LOOSE. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 160MG/DL. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7106266 ↗
• MalfunctionNov 7, 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 UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO REPORTED 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. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7008474 ↗
• MalfunctionSep 15, 2017No 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 CALLED STATING THAT HE CHANGED THE BATTERY AND GOT A FAILED BATTERY TEST, TRIED 4 DIFFERENT BATTERIES AND THE ISSUE CONTINUED. THE CUSTOMER STATED THAT NOW THE DISPLAY SCREEN WILL NOT COME UP AT ALL AND IS NOW COMPLETELY BLANK. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6870932 ↗
• InjurySep 6, 2017Break; Crack; No Display/Image; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY AFTER THE BATTERY WAS CHANGED DUE TO A BLANK DISPLAY. THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. BLANK DISPLAY TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE BATTERY CAP WAS FOUND TO BE CRACKED DUE TO WEAR AND TEAR. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS DROPPED. THE BATTERY CAP, COMPARTMENT, AND SPRINGS WERE NOT DAMAGED. THE CUSTOMER WAS INSTRUCTED TO INSERT A NEW BATTERY AND THE DISPLAY RETURNED. BUTTON ERROR/KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED DUE TO AN ALARM NOT BEING ABLE TO BE CLEARED. THE CUSTOMER ALSO STATED THAT THE INSULIN BEING DROPPED WAS THE SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUES. WHEN ASKED IF THE TIME ON THE CLOCK ADVANCED WHEN MONITORED FOR ONE MINUTE, THE CUSTOMER STATED THAT THEY WERE UNABLE TO ADJUST THE TIME. 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 6846389 ↗
• MalfunctionAug 18, 2017No Display/Image; Improper or Incorrect Procedure or Method; Moisture or Humidity Problem

  THE CUSTOMER REPORTED THAT HER INSULIN PUMP GOT WET. IT WAS WORKING BUT WHEN THE CUSTOMER CHANGED THE INFUSION SET, THE SCREEN IS SHOWING BLACK LINES AND BLACK BOXES. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP IS FLASHING NUMBERS, STOPPING AND REPEATING. THE CUSTOMER WAS ADVISED TO DISCONTINUE PUMP THERAPY AND RETURN THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6804591 ↗
• MalfunctionAug 18, 2017Moisture Damage; Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS EXPOSED TO MOISTURE. TROUBLESHOOTING FOR PUMP EXPOSED TO FLUID WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 248 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE TYPE OF FLUID/MOISTURE EXPOSURE TO THE INSULIN PUMP WAS POOL WATER. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP WAS EXPOSED TO FLUID IN THE PAST WITH NO MOISTURE VISIBLE. AFTER EXPOSURE TO FLUID, THE CUSTOMER NOTICED MORE OR FREQUENT WATCHDOG TIMEOUT ALARM. ALARM HISTORY COULD NOT BE REVIEWED DUE TO A KEYPAD ANOMALY. TROUBLESHOOTING FOR THE ALARM WAS PERFORMED AND ITS CAUSES WERE EXPLAINED. TROUBLESHOOTING FOR BUTTON ERROR/KEYPAD ANOMALY WAS PERFORMED. THE CUSTOMER STATED THAT THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER ALSO STATED THAT GETTING INTO A POOL WAS THE SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUES. 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. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6804320 ↗
• MalfunctionJun 22, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL COMPROMISED FORCE SENSOR SYSTEM ALARM ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING FOR THE PRIME REWIND WAS PERFORMED. CUSTOMER ADVISED THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER ADVISED DURING THE SEATING OF THE FORCE THE SENSOR DID NOT DETECT THE RESERVOIR. CUSTOMER DISCONNECTED THE LINE BEFORE REPLACEMENT OPTIONS WERE COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6660076 ↗

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