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

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00613994597212), received between Jun 2, 2017 and Jun 19, 2020 — classified as 9 injuries, 13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 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. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 10173477 ↗
• MalfunctionJun 4, 2020Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 26 MG/DL AT THE TIME OF THE INCIDENT AND 20 MG/DL EARLIER. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER WAS TREATED WITH FOOD. CUSTOMER WAS USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED LOW BLOOD GLUCOSE EVENT. CUSTOMER STATED THAT THEY DID NOT ALLEGING INSULIN PUMP FOR OVER DELIVERY. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10117829 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND HOSPITALIZATION. BLOOD GLUCOSE READING WAS UNKNOWN. THE CUSTOMER WAS UNRESPONSIVE AND THEY WERE TREATED VIA INSULIN DRIP. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOW BLOOD GLUCOSE INCIDENT. THE PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9920561 ↗
• InjuryMar 28, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE AND NEED TO GO EMERGENCY MEDICAL SERVICE. THE CUSTOMER WAS TREATED WITH INTRAVENOUS. THE CUSTOMER STATED THAT RESERVOIR RING WAS MISSING AND WAS ABLE TO LOCK IN PLACE. THE CUSTOMER DID NOT REPORT ANY SYMPTOMS RELATED TO LOW BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9894793 ↗
• MalfunctionOct 28, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 167 MG/DL. CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP AND THE REWIND MESSAGE OCCURRED AFTER AN ALARM OR ALERT AND THEY WERE STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. CUSTOMER STATED THAT THEY DID NOT RECEIVE 2ND SERIES OF BEEPS NOR DID NUMBERS APPEARED ON THE SCREEN. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9243696 ↗
• InjurySep 11, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OVER 1200 MG/DL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8987646 ↗
• MalfunctionMay 2, 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 UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED 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 8572882 ↗
• MalfunctionApr 3, 2019Power Problem; Power Problem

  THE DIABETES EDUCATOR REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS SHUTTING OFF EVEN AFTER BATTERY CHANGES AND SELF TEST. 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 8476860 ↗
• MalfunctionDec 31, 2018Wireless Communication Problem; Wireless Communication Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RF PIC FAILED SELF-TEST MULTIPLE TIMES. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND REPORTED THAT THEY WERE ABLE TO CLEAR AND REWIND THE INSULIN PUMP. THE CUSTOMER WAS ADVISED TO REPLACE THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205656 ↗
• InjuryAug 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVEL OF 52 MG/DL AT THE TIME OF THE INCIDENT. IT WAS ALSO STATED THAT CUSTOMER WAS ABLE TO BRING IT BACK TO 81 MG/DL. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE WITH GLUCOSE / CARB INTAKE. THE CUSTOMER DECLINED TROUBLESHOOTING AS SHE BELIEVES THAT INFECTION HAS CAUSED HER LOW READINGS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7829192 ↗
• InjuryApr 17, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE LEVEL. CUSTOMER STATED SHE WAS ONCE LOW BLOOD GLUCOSE LEVEL WAS 35 MG/DL AND TREATED BY DRINKING JUICE AND STATED SHE WAS HIGH BLOOD GLUCOSE LEVEL WAS 595 MG/DL AND TREATED BY BOLUS USING THE PUMP. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH AND LOW BLOOD GLUCOSE. CUSTOMER WILL BE RETURNED DEVICE FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7436888 ↗
• MalfunctionApr 13, 2018Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. A COLD RESET WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. CUSTOMER WILL NOT BE RETURNED DEVICE FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7430487 ↗
• MalfunctionApr 8, 2018Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD AN UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 131 MG/DL. THE CUSTOMER STATED THAT THE PUMP HAD AN UNEXPECTED RESTART ALARM . THE TROUBLESHOOTING WAS PERFORMED AND CHANGED THE BATTERY AND RECEIVED ANOTHER UNEXPECTED RESTART ALARM. THE CUSTOMER ADVISED THAT THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER ADVISED TO MONITOR THE PUMP AND THAT PATIENT MAY CONTINUE TO WEAR THE PUMP UNTIL REPLACEMENT ARRIVES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405989 ↗
• InjuryFeb 15, 2018Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF OVER 600 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE WAS 483 MG/DL. THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS SUCH AS HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED BY BOLUS WITH PUMP. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. CUSTOMER STATES THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER PERFORMED SELF-TEST AND IT DID PASS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. BASED ON CUSTOMER REPORT CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7274526 ↗
• MalfunctionJan 5, 2018Device Displays Incorrect Message; Material Protrusion/Extrusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS PROTRUDING. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS NOT PROVIDED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7170264 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 20 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 37 MG/DL AT THE TIME OF ADMISSION, AND 176 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN GLUCAGON SHOT TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS A SEIZURE AND LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7159079 ↗
• InjuryDec 26, 2017Insufficient Device Problem Information

  CUSTOMER REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 46 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 101 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER REPORTED AN INFUSION SET SITE INFECTION THAT MAY HAVE LED TO THE LOW. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia; Unspecified Infection

  MAUDE report 7145774 ↗
• InjuryAug 31, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMERS PARENT REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS OF 400 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE LEVELS WITH MANUAL INJECTION AND INSULIN PUMP. NO FURTHER INFORMATION FOR HIGH BLOOD GLUCOSE IS PROVIDED. PUMP WILL RETURN DUE TO COSMETIC DAMAGE ON PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 6835091 ↗
• MalfunctionAug 30, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY AND A BATTERY OUT LIMIT ALARM. THE CUSTOMER¿S BLOOD GLUCOSE WAS 234 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE AFTER IT HAS BEEN EXPOSED TO MOISTURE. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED TO HAVE RECEIVED A BATTERY OUT LIMIT ALARM AFTER THE BATTERY HAS BEEN CHANGED. NO TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO 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 6833049 ↗
• MalfunctionAug 1, 2017Break

  CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE WAS BROKEN AND THE RESERVOIR WOULD NOT STAY IN. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS¿ INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6758713 ↗
• MalfunctionJun 6, 2017Crack; No Display/Image; Failure to Power Up; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 223 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT SHE RECEIVED A LOW BATTERY ALERT, REPLACED THE BATTERY AND THE PUMP WILL NOT TURN ON. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND FOUND THAT THERE IS A CRACK ON THE TOP OF THE BATTERY HOUSING. CUSTOMER ALSO MENTIONED THAT THE BATTERY CAP IS HARD TO REMOVE. 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 6615305 ↗
• MalfunctionJun 2, 2017Defective Component; Device Displays Incorrect Message

  THE CUSTOMER REPORTED EXPERIENCING A MOTOR ERROR ALARM AND UNEXPECTED RESTART ERROR ALARM ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED AND THE CUSTOMER'S BLOOD GLUCOSE WAS NOT PROVIDED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610057 ↗

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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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