PARADIGM® REAL-time MMT-522NAS (UDI 00613994372055)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00613994372055), received between Jun 12, 2017 and Jun 9, 2020 — classified as 2 deaths, 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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.

• DeathJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER PASSED AWAY IN HOSPITAL. THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2020. THE CAUSE OF DEATH WAS A BRAIN ANEURYSM. THE CALLER STATED THAT THE CUSTOMER HAD DEMENTIA THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE INSULIN PUMP HAD BEEN DISCONNECTED 2 YEARS PRIOR TO PASSING DUE TO CUSTOMER HAVING DEMENTIA. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMPS FOR ANALYSIS. THIS REPORT IS BEING MADE FOR THE FAILURE ANALYSIS RESULTS. THE PUMP HAD INTERMITTENT BUTTON RESPONSE ON THE ESC AND ACT BUTTONS DUE TO FLATTENED DOME SWITCHES (NO CREASE).

  Patient problems: Death

  MAUDE report 10132236 ↗
• MalfunctionSep 26, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 233 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE ALARM OCCURRING. THE CUSTOMER WAS UNSURE THAT THE DRIVE SUPPORT CAP APPEARS NORMAL OR RECESSED. 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 9121643 ↗
• MalfunctionSep 20, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR NOT WORKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER STATED THAT SHE WANTED FULL BOLUS BUT IT WOULD PARTIALLY GAVE THE BOLUS. CUSTOMER STATED THAT THE INSULIN PUMP WAS ACTING SLOW AND SHE HAD A HYPERGLYCEMIA. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9096388 ↗
• MalfunctionSep 18, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 115 MG/DL. THE CUSTOMER WAS ALSO 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081174 ↗
• MalfunctionSep 12, 2019Failure to Cycle; Use of Device Problem; Material Integrity Problem; Patient Device Interaction Problem; Failure to Cycle; Use of Device Problem; Material Integrity Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THERE WAS HAIRLINE CRACK IN RESERVOIR COMPARTMENT. CUSTOMER STATED THAT BATTERY CAP WAS CRACKED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9005593 ↗
• MalfunctionAug 26, 2019Failure to Cycle; Failure to Cycle

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER¿S BLOOD GLUCOSE WAS 132 MG/DL. CUSTOMER STATED THAT INSULIN PUMP WAS ABLE TO REWIND. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8930098 ↗
• MalfunctionAug 19, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE RESERVOIR COMPARTMENT WAS DAMAGED AND BROKEN. 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 8905238 ↗
• MalfunctionJul 12, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 133 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783855 ↗
• MalfunctionJan 8, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM AND STICKY BUTTONS A SWELL AS SCREEN WAS HARD TO READ DUE TO BACK LIGHT ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8229967 ↗
• MalfunctionDec 18, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD SOME TYPES OF ALARMS AND WENT OFF. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8177507 ↗
• MalfunctionNov 19, 2018Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD REWIND ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT RESERVOIR COMPARTMENT WAS CHIPPED WHERE RESERVOIR SCREWED IN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8083258 ↗
• MalfunctionOct 23, 2018Priming Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM DURING PRIME. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT DROPPED OR BUMPED PRIOR TO THE ALARM OCCURRING. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. 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 7993878 ↗
• InjuryFeb 7, 2018High Test Results; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A HIGH BLOOD GLUCOSE VALUE OF 425 MG. REPORTEDLY, THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE DEVICE IS UNKNOWN TO BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7249500 ↗
• InjuryJan 12, 2018Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 450 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 483 MG/DL. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7187322 ↗
• MalfunctionDec 18, 2017Device Inoperable; 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 218 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE PUMP HAD A MALFUNCTION, WHILE ABOUT TO PRIME IT AND IT WAS STARTED OUT THE PRIME AND THEN HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSHING. TROUBLESHOOT WAS PERFORMED AND EXPLAINED THE POSSIBLE CAUSE OF THE COMPROMISED FORCE SENSOR SYSTEM ALARM WAS DURING SEATING THE FORCE SENSOR DID NOT DETECT THE RESERVOIR. THE CUSTOMER WAS ADVISED THAT THE PUMP NEEDS TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127562 ↗
• MalfunctionAug 24, 2017No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 140 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP WAS BLANK AND BEEPS LIKE IT'S ALARMING. CUSTOMER ALSO REPORTED THAT HE WORKS OUTSIDE AND THE INSULIN PUMP COULD HAVE BEEN EXPOSED TO EXTREME TEMPERATURE OR DIRECT SUNLIGHT THAT LED TO BLANK DISPLAY. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND THE DISPLAY DID NOT RETURN TO NORMAL AFTER IT HAS BEEN STABILIZED AT ROOM TEMPERATURE. 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 EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6817140 ↗
• MalfunctionAug 1, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR WHILE TRYING TO DELIVER A BOLUS . THE 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 INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6758689 ↗
• MalfunctionJun 19, 2017Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY DROPPED THE INSULIN PUMP YESTERDAY AND WAS CURRENTLY TRYING TO LOAD IT BUT WAS GETTING A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 198 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THEY DID NOT PRESS THE DRIVE SUPPORT CAP WHILE CONNECTED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE 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 6649772 ↗
• DeathJun 12, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CAUSE OF DEATH WAS A DIABETIC LOW BLOOD GLUCOSE INCIDENT. THE CALLER STATED THAT THE CUSTOMER HAD DIABETES COMPLICATIONS ¿ THE CUSTOMER HAD A LOW BLOOD GLUCOSE INCIDENT WHILE IN THE SHOWER. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH, AS IT HAD BEEN DISCONNECTED BY THE CUSTOMER SHORTLY BEFORE GETTING INTO THE SHOWER AND PASSING. THE NEXT OF KIN WAS UNSURE IF THE CUSTOMER WAS USING SENSORS. THE CALLER AGREED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 6635800 ↗

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