Paradigm® REAL-Time Revel™ MMT-523NAL (UDI 00613994904287)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00613994904287), received between Aug 1, 2017 and Dec 31, 2019 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2019Failure to Cycle; Failure to Cycle

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AND IT SHUTS DOWN AND IT RESTARTED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL OR RECESSED. THE CUSTOMER REPORTED THAT THEY WERE NOT RECOGNIZING THE RESERVOIR IN THE INSULIN PUMP AND IT WAS SQUIRTING INSULIN OUT. THE CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE INSULIN CONTINUED TO DRIP AFTER MOTOR STOPPED DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP AND WERE STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. 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 9534458 ↗
• MalfunctionDec 31, 2019Failure to Cycle; Mechanical Problem; Failure to Cycle; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A COMPROMISED FORCE SENSOR SYSTEM ALARM AND IT SHUTS DOWN AND IT RESTARTED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL OR RECESSED. THE CUSTOMER REPORTED THAT THEY WERE NOT RECOGNIZING THE RESERVOIR IN THE INSULIN PUMP AND IT WAS SQUIRTING INSULIN OUT. THE CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE INSULIN CONTINUED TO DRIP AFTER MOTOR STOPPED DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THEY WERE UNABLE TO EXIT THE PREPARING TO PRIME LOOP AND WERE STUCK IN REWIND COMPLETE OR BOLUS DELIVERY LOOP. THE CUSTOMER STATED THAT THEY HAD MOTOR ERROR ALARM BEFORE. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9534226 ↗
• MalfunctionNov 28, 2019Mechanical Problem; Battery Problem; Mechanical Problem; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPLAINED MOTOR ERRORS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE INSULIN PUMP WOULD NOT HOLD A CHARGE, FREQUENTLY BATTERY CHANGES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9388265 ↗
• MalfunctionNov 20, 2019Display or Visual Feedback Problem; Use of Device Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Display or Visual Feedback Problem; Use of Device Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD SCRATCHES ON SCREEN THAT EFFECT THE VISIBILITY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM AND WHEN CHANGING THE BATTERIES THE INSULIN PUMP RESET ITSELF EVERY TIME. THE DEVICE WILL NOT BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9347014 ↗
• InjuryAug 13, 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 HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OF OVER 600 MG/DL, AT THE TIME OF HOSPITALIZATION. CUSTOMER WAS TREATED WITH LIQUID INSULIN AND FLUIDS FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER'S ANOTHER BLOOD GLUCOSE LEVEL WAS 241 MG/DL. CUSTOMER WAS ASSISTED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER REPORTED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP AND PERFORMED HIGH PRESSURE TEST SUCCESSFULLY. CUSTOMER REPORTED THAT THE INSULIN WAS AUTOMATICALLY DELIVERED BY AUTO MODE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8886415 ↗
• MalfunctionApr 3, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR ALARM. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 186 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER REPORTS THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER STATED THAT THE INSULIN PUMP NOT EXPOSED TO MAGNETIC RESONANCE IMAGE. 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 8476920 ↗
• InjuryNov 14, 2018Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE LEVELS OF 30 MG/DL. THE CUSTOMER WAS TREATED FOR THE LOW BLOOD GLUCOSE GLUCAGON. CUSTOMER STATED THAT THEY RECEIVED BUTTON ERROR ALARM AND ACT BUTTON WAS NOT AS RESPONSIVE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8068206 ↗
• InjuryOct 24, 2017Failure to Deliver; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF OVER 500 MG/DL. CUSTOMER'S BLOOD GLUCOSE READING WAS 445 MG/DL AT THE TIME OF CALL AND 600 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP HAD A MOTOR ERROR ALARM AND UNABLE TO DELIVER INSULIN. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FEELING SICK AND VOMITING. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP GREATER THAN 48 HOURS PRIOR TO HOSPITALIZATION. NO TROUBLESHOOTING WAS PERFORMED DUE TO INSULIN PUMP WAS STUCK IN TIME/DATE SCREEN. THE INSULIN PUMP IS BEING REPLACED AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6972359 ↗
• MalfunctionAug 19, 2017Device Displays Incorrect Message; Moisture or Humidity Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR AFTER IT HAS BEEN EXPOSED TO POOL WATER. NO SIGNIFICANT EVENT LEADING TO BUTTON ERROR OR KEYPAD ANOMALY WERE OBSERVED. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND UNABLE TO CONFIRM IF THE TIME IS ADVANCING. CUSTOMER ALSO REPORTED THAT A CONSTANT TONE IS OCCURRING IN THE INSULIN PUMP. 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 6806486 ↗
• MalfunctionAug 1, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SYSTEM SENSOR. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 200 MG/DL AT THE TIME OF INCIDENT. THE PRODUCT WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6757347 ↗
• InjuryAug 1, 2017Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WENT TO THE EMERGENCY ROOM ON (B)(6) 2017 AT 7:00 A.M. DUE TO HIGH BLOOD GLUCOSE. THEY HAD TRIED TREATING WITH A BOLUS BUT IT WOULD NOT GO DOWN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL DURING THE INCIDENT WAS 400 MG/DL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF ADMISSION WAS 250 MG/DL. IT WAS NOTED THAT THEIR HEALTH CARE PROFESSIONAL CHANGED THE PROGRAM SETTING OF THE INSULIN PUMP. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6757221 ↗

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-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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• 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