Paradigm® REAL-Time Revel™ MMT-523NAB (UDI 00643169446380)Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00643169446380), received between Jun 6, 2017 and Feb 13, 2020 — classified as 36 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (32 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2020Mechanical Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD CRACK AT THE TOP OF RESERVOIR. REWIND PROCESS WAS LONGER. THE INSULIN PUMP HAD NO DELIVERY ALARMS. THE INSULIN PUMP WAS REJECTED NEW BATTERIES. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WAS NOT RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9705704 ↗
• MalfunctionFeb 4, 2020Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT PISTON WAS NOT WORKING AND RESERVOIR HOUSING CRACKED. 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 9663422 ↗
• MalfunctionDec 24, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INSULIN PUMP RECEIVED COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THE INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. 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 9515830 ↗
• InjuryNov 1, 2019Device Difficult to Program or Calibrate; No Apparent Adverse Event; Device Difficult to Program or Calibrate; No Apparent Adverse Event

  IT WAS REPORTED THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL AND OTHER BLOOD GLUCOSE VALUE WERE 300 MG/DL AND 310 MG/DL. CUSTOMER WAS TREATED WITH MANUAL INJECTION. CUSTOMER¿S FATHER ALSO REPORTED THAT THE BUTTONS WERE NOT WORKING OR GETTING STUCK ON THE PUMP. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9265227 ↗
• MalfunctionNov 1, 2019Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP REJECTED NEW BATTERIES, REWIND WAS LOUDER, RESERVOIR CHAMBER WAS CRACKED AND CHIPPED AND HAD NO DELIVERY ALARMS. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9264860 ↗
• InjurySep 18, 2019No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 548 MG/DL AND 382 MG/DL. THE CUSTOMER STATED THAT THE RESERVOIR LIP RING WAS NOT DAMAGED. CUSTOMER STATED THAT THERE TOP PART OF INSULIN PUMP WAS DAMAGED. THE CUSTOMER DID NOT WANT TO TROUBLESHOOT. 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: Hyperglycemia

  MAUDE report 9080799 ↗
• MalfunctionSep 16, 2019Battery Problem; Connection Problem; Patient Device Interaction Problem; Battery Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD CHIPPED AT THE OPENING OF RESERVOIR COMPARTMENT. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THEY CHANGED BATTERIES FOR EVERY 6 TO 7 DAYS. CUSTOMER REPORTED THE RESERVOIR DID NOT SCREW IN AS TIGHT AS IT USED TO. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069068 ↗
• MalfunctionSep 9, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE ALL BUTTONS WAS UNRESPONSIVE. CUSTOMER DID ASSIST WITH TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUED THE INSULIN PUMP AND REVERT TO BACKUP PLAN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8973533 ↗
• MalfunctionAug 27, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR AND MOTION SENSOR TEST FAILURE. THE CUSTOMER¿S BLOOD GLUCOSE WAS 300 MG/DL AT THE TIME OF INCIDENT. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM AND ABLE TO COMPLETE INSULIN PUMP REWIND. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. 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: No Consequences Or Impact To Patient

  MAUDE report 8933994 ↗
• MalfunctionAug 13, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT HER INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 86 MG/DL. THE CUSTOMER WAS ASSISTED IN TROUBLESHOOTING AND IT WAS REPORTED THAT THE CUSTOMER WAS ABLE TO CLEAR THE ALARM BUT WAS UNABLE TO REWIND THE INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8886774 ↗
• MalfunctionJul 30, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD ERROR ON KEYPAD. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE THE USE OF INSULIN PUMP AND REVERT TO BACK UP PLAN. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8839963 ↗
• MalfunctionJun 7, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT INSULIN PUMP HAD BUTTON ERROR ALARM. BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER CHANGED BATTERY BUT SAME ISSUE WAS PERSIST. 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 NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677804 ↗
• MalfunctionMay 29, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Communication or Transmission Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Communication or Transmission Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD UNRESPONSIVE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS NOT ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATED THAT THE ACT BUTTON WAS HARDER TO PRESS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8648810 ↗
• MalfunctionMay 7, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BATTERY LIFE WAS DIMINISHED, PUMP OCCASIONALLY GAVE RANDOM NO DELIVERY ALARMS, HAD GIVEN ONE MOTOR ERROR AND HALF OF THE RESERVOIR COMPARTMENT OPENING WAS BROKEN OFF AND THE INSULIN PUMP HAD ONCE REJECTED A NEW BATTERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8585034 ↗
• MalfunctionMay 3, 2019Obstruction of Flow; Patient Device Interaction Problem; Priming Problem; Obstruction of Flow; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A SCRATCHES ON SCREEN UNDER THE TIME OR DATE AREA, INSULIN SQUIRTED OUT THOROUGH INSULIN PUMP. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND CALIBRATION ERROR. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8576527 ↗
• MalfunctionApr 26, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER'S FATHER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP HAD BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER ALSO STATED THAT THEY WERE NOT ABLE TO PRESS ANY BUTTONS. 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 8554048 ↗
• MalfunctionApr 22, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD DAMAGE AND THE O-RINGS OF THE RESERVOIR WERE LOOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. RESERVOIR NOT ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 8535006 ↗
• MalfunctionApr 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 265 MG/DL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8534143 ↗
• InjuryApr 16, 2019Insufficient Flow or Under Infusion; No Apparent Adverse Event; Insufficient Flow or Under Infusion; No Apparent Adverse Event

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE OF THE PATIENT WAS 168 MG/DL. CUSTOMER WAS TREATED WITH INSULIN PUMP AND MANUAL INJECTION. CUSTOMER ALLEGE INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER HAD NOT USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8517682 ↗
• InjuryApr 9, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 422 MG/DL AND TREATED WITH INSULIN PUMP. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8498233 ↗
• MalfunctionMar 29, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP SCREEN WAS SCRATCHED WHICH MAKE SCREEN HARD TO READ. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP RECEIVED ERROR ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8463568 ↗
• MalfunctionMar 28, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER'S STEP-MOTHER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD THE BELT CLIP WAS BROKEN AND THE B BUTTON COVER WAS MISSING. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8462800 ↗
• MalfunctionMar 7, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD RECEIVED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398398 ↗
• MalfunctionMar 6, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS CRACKED IN TWO DIFFERENT PLACES AT RESERVOIR AND BATTERY COMPARTMENT. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS UNKNOWN. 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 8397760 ↗
• MalfunctionFeb 11, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY. BLOOD GLUCOSE VALUE WAS 97 MG/DL AT THE TIME OF THE INCIDENT. THE CALLER STATED THAT THEY WERE UNABLE TO GET INSULIN DELIVERY DUE TO KEYPAD ANOMALY. TROUBLESHOOTING WAS NOT ABLE TO BE PERFORMED. THE KEYPAD ANOMALY WAS NOT FIXED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8328628 ↗

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-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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• 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-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