Paradigm® REAL-Time Revel™ MMT-523NAB (UDI 00643169507166)Recalls & reported problems

Summary

The FDA's MAUDE database contains 546 adverse event reports that list this exact device (DI 00643169507166), received between May 12, 2017 and Jun 23, 2021 — classified as 3 deaths, 210 injuries, 333 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (82 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 546 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2021Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM. THE CUSTOMER STATED THEY WERE ABLE TO CLEAR THE ALARM AND WERE ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER STATED THAT THE SCREEN WAS FLASHED AND THEN STOPPED. CUSTOMER REPORTED THAT THE ALARM DID NOT APPEAR ON THE SCREEN. CUSTOMER RECEIVED RECURRING MOTOR ERROR ALARM. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 12055376 ↗
• MalfunctionAug 10, 2020Battery Problem; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP REJECTED THE NEW BATTERIES. 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 10387968 ↗
• MalfunctionAug 6, 2020Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP BUTTON WAS HARDER TO PRESS. THE CUSTOMER STATED THAT THE INSULIN PUMP REWIND MORE THAN ONCE, NO DELIVERY ALARM. CUSTOMER STATED THAT THE INSULIN PUMP HAD COSMETIC DAMAGE. CUSTOMER STATED THAT THE INSULIN PUMP REJECT NEW BATTERY. 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 10372746 ↗
• MalfunctionJul 24, 2020Failure to Cycle; Device Difficult to Program or Calibrate; Detachment of Device or Device Component; Failure to Cycle; Device Difficult to Program or Calibrate; Detachment of Device or Device Component

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NOT NORMAL. CUSTOMER STATED INSULIN PUMP GOT BUTTON STOP ALARM. 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 10319014 ↗
• MalfunctionJul 20, 2020Mechanical Problem; Battery Problem; Power Problem; Priming Problem; Mechanical Problem; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD STICKY BUTTONS. CUSTOMER REPORTED THAT THE INSULIN PUMP REJECTED NEW BATTERY, NO DELIVERY ALARMS. THE INSULIN SQUIRTED DURING PRIMING. CLOCK HAD BEEN PROGRAMMED. 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 10294783 ↗
• MalfunctionJul 20, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE RESERVOIR KEEPS FALLING OUT OF THE PUMP. THE CUSTOMER STATED THAT, THE RETAINER RING ON THE PUMP IS MISSING. 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 10294680 ↗
• MalfunctionJul 14, 2020Mechanical Problem; Intermittent Communication Failure; Mechanical Problem; Intermittent Communication Failure

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP RECEIVED MOTOR POSITION ENCODER ERROR ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 10270177 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 500 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10256854 ↗
• MalfunctionJul 9, 2020Failure to Cycle; Failure to Cycle

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 10250038 ↗
• MalfunctionJul 9, 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 HAD COMPROMISED FORCE SENSOR SYSTEM ALARM. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NOT NORMAL. 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 10249925 ↗
• MalfunctionJun 22, 2020Failure to Cycle; Detachment of Device or Device Component; Priming Problem; Failure to Cycle; Detachment of Device or Device Component; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THE DEVICE WAS SQUIRTING INSULIN OUT DURING MANUAL PRIME PROCESS. THE DEVICE WAS BUMPED OR DROPPED PRIOR TO THE ALARM AND THE DRIVE SUPPORT CAP APPEARS PROTRUDED. 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 10182567 ↗
• MalfunctionJun 22, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR ALARM. 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 10177571 ↗
• MalfunctionJun 18, 2020Priming Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRTING INSULIN DURING THE MANUAL PRIME PROCESS. CUSTOMER STATED THAT THEY DID NOT RECEIVE SECOND SERIES OF BEEPS NOR DID NUMBERS APPEAR ON THE SCREEN. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10167776 ↗
• MalfunctionJun 12, 2020Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL KEYPAD ANOMALY, REWIND ANOMALY, FAILED BATTERY TEST AND NO DELIVERY ALARM ON THE INSULIN PUMP. TROUBLESHOOTING WAS NOT PERFORMED. CUSTOMER ADVISED THE BUTTONS WOULD STICK, THEY RECEIVED RANDOM NO DELIVERY ALARMS, THE REWIND PROCESS WAS SLOW AND THE INSULIN PUMP HAD A FAILED BATTERY TEST. 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 10147289 ↗
• MalfunctionJun 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT RESERVOIR LIP RING WAS CHIPPING. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR WAS ABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 10141895 ↗
• MalfunctionJun 10, 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 DRIVE SUPPORT CAP WAS STICKING OUT. CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. TROUBLESHOOTING WAS PERFORMED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10138058 ↗
• InjuryJun 10, 2020Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 427 MG/DL. THE CUSTOMER ALSO STATED THAT THE RETAINER RING WAS MISSING FROM THE INSULIN PUMP AND BECAUSE OF THIS RESERVOIR WAS UNABLE TO LOCK IN PLACE. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE. CUSTOMER REPORTED THAT THEY DID CONTACT TO THEIR HEALTH CARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED FOR THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. THE DRIVE SUPPORT CAP APPEARS NORMAL. BASED ON CUSTOMER REPORT CUSTOMER DOES ALLEGE INSULIN PUMP WAS UNDER DELIVERING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10136567 ↗
• MalfunctionJun 8, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS NOT TURNING ON. CUSTOMER STATED TRIED SEVERAL DIFFERENT BATTERIES AND WAS NOT TURNING ON AND BATTERIES ARE WORKING. 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 10128329 ↗
• MalfunctionMay 29, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE ACT, UP, DOWN BUTTONS HAD TO BE PRESSED HARDER. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10100381 ↗
• MalfunctionMay 27, 2020Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE BUTTONS ON THE INSULIN PUMP WERE HARD TO PRESS AND STICKING. CUSTOMER STATED THAT THE INSULIN PUMP HAD SEVERAL CRACKS. 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 10091265 ↗
• MalfunctionMay 22, 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 HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM. 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 10081860 ↗
• MalfunctionMay 18, 2020Device Difficult to Program or Calibrate; Battery Problem; Device Difficult to Program or Calibrate; Battery Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE UP ARROW BUTTON WAS BEGINNING TO GIVE PROBLEMS AND HAD TO BE PUSHED 7 TIMES IN ORDER TO RESPOND. 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 10064798 ↗
• MalfunctionMay 14, 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 HAD COMPROMISED FORCE SENSOR ALARM AND REWIND ANOMALY. THE CUSTOMER ALSO STATED THAT, THE DRIVE SUPPORT CAP IS 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 10054828 ↗
• InjuryMay 13, 2020Adverse 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 AND GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF 30 TO 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 61 TO 110 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED FOOD AND WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED AND NO OTHER ISSUES WERE FOUND. THE CUSTOMER WAS USING A COMPETITOR'S SENSOR SYSTEM AND NO METER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 10051116 ↗
• InjuryMay 13, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED VIA PHONE CALL BY THE CUSTOMER'S SPOUSE THAT THE CUSTOMER GOT HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE WITH BLOOD GLUCOSE IN THE 491 TO 550 MG/DL RANGE AT THE TIME OF THE INCIDENTS. THE CALLER DID NOT MENTION HOW THE CUSTOMER WAS TREATED. THE CALLER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENTS. THE CALLER REPORTED THE CUSTOMER WAS GETTING NO DELIVERY ALARMS. THE CUSTOMER'S PUMP SETTINGS HAD BEEN REGULARLY ADJUSTED BY THEIR HEALTH CARE PROFESSIONALS, SET CHANGES WERE PERFORMED, AND THE INSULIN VIAL WAS CHANGED, BUT THE CUSTOMER WAS STILL HAVING HIGHS. THE CUSTOMER WOULD ONLY GO LOWER USING MANUAL INJECTIONS. TROUBLESHOOTING WAS NOT COMPLETED AS THE CALLER DECLINED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10050676 ↗

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-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-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• 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