Paradigm® REAL-Time Revel™ MMT-523LNAB (UDI 00643169479593)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169479593), received between Sep 15, 2017 and Aug 13, 2019 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTONS WERE HARDER TO PRESS AND SCRATCHES ON THE SCREEN MAKING IT HARD TO READ AND FOGGY SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER ALSO REPORTED THAT INSULIN PUMP HAD MOTOR WAS SLOWER DURING THE REWINDING AND UNEXPLAINED ALERTS NOT DUE TO SITE ISSUES. THE CUSTOMER ALSO STATED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8886566 ↗
• MalfunctionJun 26, 2019Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD UNEXPECTED RESTART AND HAD TO RESET DATE AND TOME EVERY TIME CHANGES BATTERY, SHOWS OUT OF INSULIN WHEN THERE WAS STILL INSULIN IN RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL 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 8734267 ↗
• MalfunctionDec 27, 2018Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 149 MG/DL. THE CUSTOMER REPORTED THAT THERE WAS A CRACK ON THE LIP RING. THE CUSTOMER REPORTED THAT THE RESERVOIR COMPARTMENT COULD NO LONGER HOLD THE RESERVOIR. 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: No Consequences Or Impact To Patient

  MAUDE report 8198963 ↗
• MalfunctionNov 13, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD COSMETIC DAMAGE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 104 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8063227 ↗
• InjuryOct 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE IN THE 40 MG/DL RANGE AT THE TIME OF THE INCIDENT. THE CUSTOMER BELIEVES THE LOW WAS RELATED TO STRESS. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. NO FURTHER INFORMATION WAS PROVIDED AND THE CUSTOMER COULD NOT BE REACHED BACK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8018243 ↗
• InjuryMay 21, 2018Insufficient Device Problem Information

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. TROUBLESHOOTING WAS PERFORMED FOR HIGH BLOOD GLUCOSE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7528798 ↗
• InjuryMay 3, 2018Nonstandard Device

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2018 WITH UNKNOWN BLOOD GLUCOSE LEVELS AT THE TIME OF THE INCIDENT. THE CUSTOMER ALSO MENTIONED THAT AFTER PERFORMING A SET CHANGE, THE NEW INSULIN OUT OF THE REFRIGERATOR WORKED BETTER THAN THE INSULIN THAT IS IN THE PUMP AFTER 24 HOURS. THE CUSTOMER WAS GIVEN GLUCAGON TO TREAT THE LOW. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS LOSS OF CONSCIOUSNESS. IT IS UNKNOWN IF THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER ALSO CALLED ABOUT SENDING BACK RECALLED SETS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7482467 ↗
• InjuryApr 24, 2018Break; Detachment Of Device Component

  THE CUSTOMER REPORTED VIA PHONE CALL THAT A PIECE OF RESERVOIR LIP RING WAS BROKEN OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS LITTLE BIT OVER 200 MG/DL. THE CUSTOMER WAS ASSISTED WITH THE TROUBLESHOOTING. THE CUSTOMER STATED THAT THE RESERVOIR COMPARTMENT WAS COMING LOOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7453386 ↗
• InjuryJan 17, 2018Bent

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THEY CORRECTED WITH A BOLUS FROM THE INSULIN PUMP. THE CUSTOMER REPORTED CANNULA WAS BENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7200286 ↗
• InjuryJan 4, 2018Inaccurate Delivery; High Test Results

  THE CUSTOMER¿S HEALTH CARE PROFESSIONAL REPORTED VIA PHONE CALL THAT THE PATIENT¿S BLOOD GLUCOSE WAS HIGH. THE CUSTOMER¿S HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT WAS HOSPITALIZED TO DUE DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2017. THE CUSTOMER WAS CURRENTLY ON INSULIN DRIP. PATIENT'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 550 MG/DL. PATIENT'S CURRENT BLOOD GLUCOSE WAS 296 MG/DL. THE CUSTOMER TREATED FOR HIGH BLOOD GLUCOSE WITH INTRAVENOUS DRIP. BLOOD GLUCOSE VALUE WHEN ADMITTED TO HOSPITAL WAS 422 MG/DL. THE CUSTOMER WAS WEARING THE PUMP AT TIME OF HOSPITALIZATION. BASED ON CUSTOMER REPORT, CUSTOMER DOES NOT ALLEGE PUMP WAS UNDER DELIVERING. CUSTOMER STATED THE DRIVE SUPPORT CAP APPEARS NORMAL (SLIGHTLY INDENTED). THE CUSTOMER DECLINED TO COMPLETE HIGH BLOOD GLUCOSE TROUBLESHOOTING AND MOVED TO BOLUS WIZARD TROUBLESHOOTING. THE CUSTOMER ENTERED 300 MG/DL AND HAS ESTIMATED TOTAL OF 0.0 WITH NO ACTIVE INSULIN. THE TROUBLESHOOTING DETERMINED THAT THE PUMP DID NOT MAKE CORRECT CALCULATIONS BASED ON INFORMATION ENTERED. 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 TH

  Patient problems: Hyperglycemia

  MAUDE report 7164761 ↗
• InjurySep 25, 2017Failure to Deliver; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED NO DELIVERY ALARM. THE CUSTOMER'S BLOOD GLUCOSE WAS 446 MG/DL AT THE TIME OF INCIDENT. ADVISED TO REWIND PUMP, REINSERT RESERVOIR INTO PUMP AND RUN MANUAL PRIME TO AT LEAST 5.0 UNITS. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. CUSTOMER STATES THE PUMP DID NOT ALARM NO DELIVERY. ADVISED THE PUMP IS WORKING AS DESIGNED. THE CUSTOMER WAS ADVISED TO REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6890308 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 404 MG/DL AT THE TIME OF THE INCIDENT. PRODUCT WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6870077 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-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-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