Paradigm® REAL-Time Revel™ MMT-523RNAS (UDI 00613994748706)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00613994748706), received between Aug 23, 2017 and Aug 6, 2020 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 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 BUTTONS WERE HARDER TO PRESS. CUSTOMER REPORTED THAT THE INSULIN PUMP SCREEN WAS SCRATCHED BUT NOT DIFFICULT TO READ. 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 10372653 ↗
• MalfunctionOct 31, 2019Connection Problem; No Apparent Adverse Event; Patient Device Interaction Problem; Connection Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PIECE MISSING THAT HOLDS THE RUBBER PIECE. THE CUSTOMER REPORTED THAT THE RESERVOIR COMPARTMENT WAS DAMAGED AND THE RESERVOIR WAS NOT ABLE TO LOCK IN PLACE. THE BLOOD GLUCOSE OF THE CUSTOMER WAS 173 MG/DL. THE CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTION. THE DEVICE WILL BE RETURNED FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9260448 ↗
• MalfunctionApr 11, 2019Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Priming Problem; Display or Visual Feedback Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE ACT BUTTON WAS STICKING AND THE SCREEN WAS HARDER TO READ AND FOGGIER. CUSTOMER ALSO STATED THAT THE INSULIN PUMP PRIMES SLOWER DURING REWIND AND BACKLIGHT IS DIMMER. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8502835 ↗
• MalfunctionJan 23, 2019Infusion or Flow Problem; Infusion or Flow Problem

  CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD PRIMING ANOMALY. INSULIN PUMP WAS SQUIRTING AND DOES NOT STOP REWINDING. TROUBLESHOOTING WAS NOT COMPLETED. CUSTOMER IS NOT USING THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8272161 ↗
• InjuryDec 10, 2018Adverse 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 LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN THE RANGE OF HIGH 50 MG/DL, 60 MG/DL AND IN THE RANGE OF 60 MG/DL TO 70 MG/DL. THE CURRENT BLOOD GLUCOSE LEVEL IS 111 MG/DL. THE CUSTOMER TREATED FOR LOW BLOOD GLUCOSE VALUE WITH FOOD. BASED ON CUSTOMER¿S REPORT CUSTOMER ALLEGE THE INSULIN PUMP WAS OVER DELIVERING REASON THAT THEY RECEIVED A REMINDER OF A MISSED BOLUS AFTER DELIVERING A BOLUS AND THEN WENT LOW. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. THE CUSTOMER WAS WEARING THE INSULIN PUMP WHEN LOW BLOOD GLUCOSE EVENT WAS REPORTED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 8145895 ↗
• MalfunctionOct 30, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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 BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8018158 ↗
• MalfunctionAug 7, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 373 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER HAD A HIGH BLOOD GLUCOSE OF 554 MG/DL AND TREATED WITH MANUAL INJECTION. CUSTOMER DECLINED HIGH BLOOD GLUCOSE TROUBLESHOOTING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7759965 ↗
• InjuryJul 19, 2018Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO COLITIS AND HIGH BLOOD GLUCOSE ON (B)(6) 2018 WITH BLOOD GLUCOSE OF 385 MG/DL. THE CUSTOMER WAS TREATED WITH IV DRIPS. CUSTOMER'S BLOOD GLUCOSE WAS 214 MG/DL AT THE TIME OF CALL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A BUTTON ERROR AND THE BUTTONS WERE UNRESPONSIVE. AND CONFIRMED THAT THE TIME WAS ADVANCING. 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. FRN-RESERVOIR.

  Patient problems: Hyperglycemia

  MAUDE report 7701718 ↗
• MalfunctionMay 17, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER WAS DECLINED FOR TROUBLESHOOTING. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7521321 ↗
• InjuryFeb 27, 2018High Test Results; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS RANGING FROM 300-400MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP. THE CUSTOMER STATES THE PUMP BATTERY DRAINS QUICKLY. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF PUMP AND REVERT TO BACK-UP PLAN. THE CUSTOMER DECLINED TO TROUBLE SHOOT FOR HIGH BLOOD GLUCOSE LEVELS. THE INSULIN PUMP IS BEING REPLACED AND IS EXPECTED TO RETURN FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7300748 ↗
• InjuryNov 14, 2017Device Displays Incorrect Message

  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 AND THE NUMBERS RAMP UP WHILE TRYING TO DELIVER A BOLUS. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS ADVANCING. CUSTOMER ALSO REPORTED THAT SHE HAD AN INSULIN REACTION AND PARAMEDICS CAME OUT AND SHE WAS TREATED WITH GLUCOSE. CUSTOMER REPORTED THAT SHE GAVE TOO MUCH INSULIN THAT RESULTED IN LOW BLOOD GLUCOSE. 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: Hypoglycemia

  MAUDE report 7031590 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVEL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF INCIDENT WAS 39 MG/DL. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 150 MG/DL. THE CUSTOMER WAS TREATED WITH GLUCOSE TABLETS FOR LOW BLOOD GLUCOSE. THE DRIVE SUPPORT CAP WAS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 6912910 ↗
• MalfunctionAug 23, 2017Break; Crack; Retraction Problem; Device Displays Incorrect Message; Communication or Transmission Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED MOTOR ERROR. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT REPORTED. HER INSULIN PUMP WAS NOT BEEN ABLE TO COMMUNICATE WITH HER METER, SHE WAS ENTERING HER BLOOD GLUCOSE LEVELS MANUALLY. THE INSULIN PUMP WAS STUCK IN THE REWIND LOOP. THE DRIVE SUPPORT CAP WAS CRACKED AND HALF OF IT WAS MISSING. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6815329 ↗

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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• 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