PARADIGM® REAL-time MMT-522LNALRecalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00613994407719), received between Jun 3, 2017 and Jul 9, 2020 — classified as 19 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (14 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2020Device Difficult to Program or Calibrate; Moisture or Humidity Problem; Device Difficult to Program or Calibrate; Moisture or Humidity Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTONS WERE NOT RESPONDING. CUSTOMER STATED INSULIN PUMP EXPOSED TO MOISTURE. 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 10250050 ↗
• MalfunctionJul 8, 2020Obstruction of Flow; Detachment of Device or Device Component; Obstruction of Flow; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE TROUBLESHOOTING WAS PERFORMED FOR DAMAGE. IT WAS STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. 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 10243613 ↗
• MalfunctionMay 12, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER BLOOD GLUCOSE AT THE TIME OF INCIDENT UNKNOWN. TROUBLESHOOT WAS NOT PERFORMED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10046011 ↗
• InjuryMay 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. CUSTOMER DECLINED TO TROUBLESHOOT FOR HOSPITALIZATION AND DIABETIC KETOACIDOSIS. CUSTOMER BEEN ON INJECTIONS THE LAST 3 DAYS. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis

  MAUDE report 10045935 ↗
• MalfunctionMay 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MULTIPLE CRACKS AND PIECE MISSING FROM THE RESERVOIR COMPARTMENT. CUSTOMER STATED THAT RESERVOIR DID LOCK IN PLACE. 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 10043825 ↗
• MalfunctionApr 6, 2020Failure to Cycle; Loss of Data; Priming Problem; Failure to Cycle; Loss of Data; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP. THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD ANOTHER INSULIN PUMP ERROR ALARM. CUSTOMER WAS ASSISTED IN PERFORMING A SELF TEST AND THE TEST PASSED. 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 9927659 ↗
• MalfunctionApr 1, 2020Battery Problem; Battery Problem

  INFORMATION PROVIDED TO MEDTRONIC INDICATE THAT THE CUSTOMERS INSULIN PUMP HAD A WEAK BATTERY CHARGE AND ALARMS. THE CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED, THE CUSTOMER RETURNED THE DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9914278 ↗
• MalfunctionMar 3, 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 ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATED THAT 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 9783529 ↗
• MalfunctionJan 15, 2020Device Alarm System; Device Difficult to Program or Calibrate; Device Alarm System; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE ESC BUTTON WAS NOT RESPONDING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER WAS UNABLE TO CLEAR THE ALARM SHE RECEIVED ABOUT LOW RESERVOIR. 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 DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590221 ↗
• MalfunctionJan 9, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Use of Device Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP BUTTONS WAS LESS RESPONSIVE AND SLOWER DURING REWIND. 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 9567499 ↗
• MalfunctionDec 24, 2019Premature Discharge of Battery; Use of Device Problem; Loss of Data; Premature Discharge of Battery; Use of Device Problem; Loss of Data

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTED THAT THE AFTER CHANGING THE BATTERY INSULIN PUMP RECEIVED ANOTHER ALARM. THE CUSTOMER WAS ADVISED TO CONTINUE TO WEAR THE INSULIN PUMP UNTIL REPLACEMENT ARRIVES. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9514817 ↗
• MalfunctionNov 20, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HOLDER WAS CRACKED AND RESERVOIR WILL NO LONGER TO SEAT CORRECTLY AND WILL NOT SEAL TO INSULIN PUMP. THE DEVICE WILL NOT RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9346502 ↗
• MalfunctionNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL WENT UPTO 322 MG/DL. CUSTOMER ALSO REPORTED THAT THEY HAD PAIN AT SITE OF INSERTION. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Discomfort; Hyperglycemia; Pain

  MAUDE report 9345600 ↗
• MalfunctionNov 13, 2019Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem; Display or Visual Feedback Problem; Mechanical Problem; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313775 ↗
• MalfunctionOct 22, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 215 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER WAS REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO X-RAYS. CUSTOMER WAS ALSO REPORTED THAT THEY WERE UNABLE TO GO TO THE STATUS SCREEN AND STUCK IN REWIND OPTION. THE CUSTOMER 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 9217346 ↗
• InjuryOct 17, 2019Obstruction of Flow; No Apparent Adverse Event; Obstruction of Flow; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED THE HYPERGLYCEMIA. THE BLOOD GLUCOSE WAS 536 MG/DL AT THE TIME OF THE INCIDENT AND CURRENT WAS 487 MG/DL. THE CUSTOMER REPORTED THAT INSULIN PUMP HAD NO DELIVERY ALARM. THE CUSTOMER WAS TREATED WITH THE MANUAL INJECTION. IT WAS REPORTED THAT INFUSION SET CANNULA WAS NOT BENT. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9200835 ↗
• MalfunctionOct 10, 2019Premature Discharge of Battery; Premature Discharge of Battery

  CUSTOMER'S WIFE REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AN UNEXPECTED RESTART ERROR ALARM AND THE BUTTON ERROR. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM AND NOT ABLE TO REWIND THE INSULIN PUMP. CUSTOMER STATED THAT THE TIME WAS ADVANCING AND INSULIN PUMP HAD FROZEN DISPLAY. CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF THE INSULIN PUMP AND REFER THE BACKUP PLAN AS PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173922 ↗
• MalfunctionMay 14, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 173 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT INSULIN PUMP HAD COSMETIC DAMAGE BOTTOM PART IS LOOSE. 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 8606600 ↗
• MalfunctionMay 10, 2019Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP SQUIRTED OUT INSULIN DURING PRIMING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. 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 8598694 ↗
• MalfunctionApr 16, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PLASTIC WAS BROKEN AT RESERVOIR AND CUSTOMER USES TAPE OVER RESERVOIR TO SECURE RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8517394 ↗
• MalfunctionFeb 26, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED THE MOTOR ERROR ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369715 ↗
• InjuryJan 16, 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 EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER'S OTHER BLOOD GLUCOSE WAS 270 MG/DL, 204 MG/DL. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BG EVENT. CUSTOMER WAS ASSISTED WITH SELF TEST AND IT WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8251903 ↗
• MalfunctionJan 8, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PIECES OF RESERVOIR COMPARTMENT WAS MISSING. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 174 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT BACK TO BACK UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8227226 ↗
• MalfunctionDec 20, 2018Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE UNRESPONSIVE AND STICKY AND SCREEN WAS HARD TO READ. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188290 ↗
• MalfunctionNov 26, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. THE BLOOD GLUCOSE LEVEL WAS 160 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8101369 ↗

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-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-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