Paradigm® REAL-Time Revel™ MMT-523LNAH (UDI 00643169479609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169479609), received between May 29, 2017 and Nov 4, 2019 — classified as 7 injuries, 8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MALFUNCTIONS. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. CUSTOMER HAD SEVERAL CRACKS ON THE PUMP. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9274894 ↗
• InjuryMar 6, 2019Power Problem; No Apparent Adverse Event; Power Problem; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 425 MG/DL AT THE TIME OF INCIDENT. THE INSULIN PUMP HAD BATTERY OUT LIMIT. CUSTOMER REPORTED THEY WERE ABLE TO CLEAR THE ALARM. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS. THE CUSTOMER WAS TREATED BY INSULIN PUMP. CUSTOMER WAS ADVISED THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8393385 ↗
• InjuryMar 5, 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 425 MG/DL. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8389409 ↗
• MalfunctionOct 22, 2018Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD PRIME FILL ANOMALY AND HAD REJECTED NEW BATTERIES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING PRIMING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7993322 ↗
• MalfunctionJul 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED IN THE RESERVOIR LIP AFTER IT WAS DROPPED AND HIT THE FLOOR. CUSTOMER STATED DUE TO THE DAMAGE THE RESERVOIR WOULD NOT LOCK IN PLACE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF THE INCIDENT. 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 7688142 ↗
• MalfunctionJun 19, 2018Break

  CUSTOMER'S MOM REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD COSMETIC DAMAGE AND DAMAGE RESERVOIR COMPARTMENT. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7612914 ↗
• MalfunctionJun 6, 2018Device Slipped

  THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS HAVING A PROBLEM WITH THE RESERVOIR STATES IT DOES NOT STAY IN THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7575798 ↗
• MalfunctionApr 2, 2018Device Displays Incorrect Message

  CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT INSULIN PUMP ALARMED FOR INSULIN PUMP ERROR AND BUTTON SEEMED TO NOT BE WORKING. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER PERFORMED TROUBLESHOOT BUT DID NOT RESOLVE THE ISSUE. CUSTOMER ADVISED TO REFER TO BACK-UP PLAN. INSULIN PUMP WILL BE RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388077 ↗
• InjuryNov 27, 2017Failure to Deliver

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) WITH BLOOD GLUCOSE OF 30 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 360 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER WAS GIVEN GLUCOSE TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CALL DROPPED. THE CUSTOMER STATED THAT THE PUMP WAS NOT GIVING THEM INSULIN AND THEN ALL OF A SUDDEN THEY GOT STUCK AT 42 MG/DL FOR A COUPLE OF HOURS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 7061586 ↗
• InjuryNov 21, 2017Component Falling; Crack

  IT WAS REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS ON (B)(6) 2017. THE CUSTOMER'S BLOOD GLUCOSE WAS 529 MG/DL AT THE TIME OF HOSPITALIZATION. IT WAS REPORTED THAT THE CUSTOMER WAS TREATED WITH INSULIN DRIP. IT WAS REPORTED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE HOSPITALIZATION. IT WAS REPORTED THAT INSULIN PUMP FELL WHEN THEY WERE CHANGING RESERVOIR. INSULIN PUMP HAD CRACK ON THE TOP OF BATTERY COMPARTMENT. CUSTOMER ADVISED TO REVERT TO BACK UP PLAN AS PER HCP¿S INSTRUCTIONS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7051384 ↗
• InjurySep 12, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 444 MG/DL. THE CUSTOMER REPORTED THAT SHE FEELS WEAK AND ISN'T THINKING PROPERLY. THE CUSTOMER TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE VALUE WAS 444 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE LEVELS BEGAN AFTER LUNCH. TROUBLESHOOTING WAS PERFORMED. THE PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6858546 ↗
• InjuryAug 30, 2017No Display/Image; Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS, FAILED BATTERY TEST AND BLANK DISPLAY ANOMALY ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 407 MG/DL. CUSTOMER TREATED THEIR HIGH BLOOD GLUCOSE VIA MANUAL INJECTION. TROUBLESHOOTING FOR THE ALARMS WERE PERFORMED. CUSTOMER REPLACED THE BATTERY ON THE INSULIN PUMP WHICH RESOLVED THE ISSUE. CUSTOMER ADVISED THE DISPLAY RETURNED AND THE SELF TEST PASSED.

  Patient problems: Hyperglycemia

  MAUDE report 6830689 ↗
• InjuryAug 23, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE ALARMED NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE WAS OVER 500 MG/DL. ALARM WAS RESOLVED BY A COMPLETE SET CHANGE. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. CUSTOMER AGREED TO RETURN SET FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6815503 ↗
• MalfunctionAug 15, 2017Low Battery; Device Displays Incorrect Message; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD A LOW BATTERY ALERT AND A FAILED BATTERY TEST ALARM ON THE INSULIN PUMP. THEY HAD BEEN HAVING BATTERY ISSUES FOR THE LAST COUPLE OF WEEKS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 121 MG/DL. TROUBLESHOOTING WAS PERFORMED. THERE WAS NO CLEAR INDICATION THAT THE ALARM WAS CLEARED. THE CUSTOMER STATED THEY WILL CALL BACK WHEN THEIR DOCTOR APPOINTMENT IS OVER. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6796328 ↗
• MalfunctionMay 29, 2017Crack; Device Displays Incorrect Message

  <P STYLE="MARGIN: 1EM 0PX;">THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD REPEATED FAILED BATTERY TEST ALARM ON THEIR INSULIN PUMP. THE CUSTOMER STATED THEY HAVE REPLACED THE ALARMS OCCURRED AFTER EVERY BATTERY REPLACEMENT. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF THE CALL. THE CUSTOMER ALSO REPORTED CRACKS ON THE INSULIN PUMP, FROM THE INSULIN PUMP'S SCREEN TO BATTERY COMPARTMENT. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER AGREED TO RETURN THE PRODUCT FOR ANALYSIS. </P><P>;</P>

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6597128 ↗

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