Paradigm® REAL-Time Revel™ MMT-523LNAL (UDI 00643169932968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00643169932968), received between Dec 28, 2017 and Aug 12, 2020 — classified as 2 deaths, 57 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (22 reports).

14 other recalls cover devices cleared under the same FDA submission (P150019, 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 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR AND 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 10394748 ↗
• MalfunctionJul 31, 2020No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY. CUSTOMER STATED THAT THE INSULIN PUMP ALSO ALERTED FAILED BATTERY. CUSTOMER TRIED FRESH BATTERY BUT STILL DISPLAY DID NOT RETURN. 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 10348659 ↗
• MalfunctionJul 31, 2020No Display/Image; Power Problem; No Display/Image; Power Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD BLANK DISPLAY AND FAILED BATTERY ALARM. CUSTOMER STATED THAT THE DISPLAY WAS BLANK LESS THAN 30 SECONDS AND THEN RETURNED. CUSTOMER STATED DISPLAY WAS BLANK CURRENTLY. IT WAS UNKNOWN WHETHER THE DISPLAY RETURN TO NORMAL AFTER INSERTION OF FRESH BATTERY OR NOT. 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 10348654 ↗
• MalfunctionJul 24, 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 THAT THE BATTERY COMPARTMENT WAS CRACKED. 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 10318785 ↗
• MalfunctionJul 23, 2020No Display/Image; Patient Device Interaction Problem; No Display/Image; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD BLANK DISPLAY. INSULIN PUMP WAS NOT WORKING AND INSULIN PUMP HAD CRACK ON IT. 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 10318196 ↗
• InjuryJul 20, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING WENT UP TO 508 MG/DL AND CUSTOMER¿S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 446 MG/DL AND IN RANGE OF 200 MG/DL TO 300 MG/DL. CUSTOMER REPORTED THAT THEY WERE UNABLE TO REWIND INSULIN PUMP AND INFUSION SET WAS LEAKING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED FOR THEIR HIGH BLOOD GLUCOSE WITH BOLUS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10294349 ↗
• MalfunctionJul 8, 2020Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE KEYPAD WAS NOT RESPONSIVE. THE BUTTONS WERE NOT RESPONDING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10244097 ↗
• InjuryJul 1, 2020Adverse 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 HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 600 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP, MANUAL INJECTION. THE CUSTOMER WAS USING THE INSULIN PUMP WHEN HIGH BLOOD GLUCOSE EVENT WAS REPORTED. THE CUSTOMER WAS REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. THE CUSTOMER WAS REPORTED THAT INSULIN PUMP PASSED HIGH PRESSURE TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10217356 ↗
• MalfunctionMar 3, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER REPORTED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER ABLE TO COMPLETE REWIND. CUSTOMER STATED THAT THEY RECEIVED THE ALARM AFTER INSERT THE NEW BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9778985 ↗
• MalfunctionFeb 20, 2020Obstruction of Flow; Power Problem; Patient Device Interaction Problem; Obstruction of Flow; Power Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE SCREEN OF INSULIN PUMP WAS SCRATCHED MAKING IT HARDER IT READ. CUSTOMER STATED THAT INSULIN PUMP REJECTED NEW BATTERIES AND HAD NO UNEXPLAINED DELIVERY ALERTS. 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 9731730 ↗
• MalfunctionFeb 18, 2020Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD MOTOR ERROR. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. 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 9719468 ↗
• InjuryFeb 17, 2020Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE. BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 400 MG/DL. CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A PUMP ERROR. CUSTOMER WAS ABLE TO CLEAR THE ALARM SUCCESSFULLY. CUSTOMER WAS ABLE TO COMPLETE PUMP REWIND. ALARM REOCCURRED AFTER A BATTERY CHANGE. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9716283 ↗
• MalfunctionFeb 11, 2020No Display/Image; Battery Problem; Patient Device Interaction Problem; No Display/Image; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPLETE BLANK SCREEN. CUSTOMER STATED THAT THE RESERVOIR COMPARTMENT AND BATTERY COMPARTMENT WAS CRACK. 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 9693386 ↗
• MalfunctionFeb 11, 2020No Display/Image; Battery Problem; Patient Device Interaction Problem; No Display/Image; Battery Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD COMPLETE BLANK SCREEN. CUSTOMER STATED THAT THE BATTERY COMPARTMENT AND RESERVOIR COMPARTMENT WAS CRACK. 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 9693355 ↗
• InjuryFeb 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. BLOOD GLUCOSE READING WAS 30 MG/DL. CUSTOMER TREATED WITH FOOD FOR LOW BLOOD GLUCOSE. CUSTOMER STATED INSULIN PUMP WAS DROPPED AND BATTERY COMPARTMENT HAD CRACK. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE LOW BLOOD GLUCOSE INCIDENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 9691757 ↗
• MalfunctionJan 31, 2020Premature Discharge of Battery; Premature Discharge of Battery

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTED THAT THE AFTER CHANGING THE BATTERY RECEIVED UNEXPECTED RESTART. 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 9650831 ↗
• MalfunctionJan 16, 2020Failure of Device to Self-Test; Failure of Device to Self-Test

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD SOME ISSUE RELATED TO HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE SPECIALLY AT THE NIGHT. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 305 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER PASSED THE SELF TEST AND DISPLACEMENT TEST. CUSTOMER ALSO PERFORMING THE HIGH PRESSURE TEST AND IT WAS FAILED TWICE. CUSTOMER WAS ADVISED TO CHANGE INFUSION TUBING AFTER PERFORMING THE HIGH PRESSURE TEST. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 9599528 ↗
• InjuryDec 31, 2019Premature Discharge of Battery; No Apparent Adverse Event; Premature Discharge of Battery; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 480 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD UNEXPECTED RESTART ALARM. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATED THAT THEY WERE ABLE TO REWIND THE INSULIN PUMP. CUSTOMER REPORTED THAT THE AFTER CHANGING THE BATTERY DID NOT RECEIVED MULTIPLE UNEXPECTED RESTART ALARMS. THE CUSTOMER WAS ADVISED TO CONTINUE TO WEAR THE INSULIN PUMP UNTIL REPLACEMENT ARRIVES. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9534571 ↗
• MalfunctionDec 30, 2019Connection Problem; Patient Device Interaction Problem; Connection Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR LIP RING WAS CRACKED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATES THE INSULIN PUMP HAS COSMETIC DAMAGE. THE CUSTOMER ALSO REPORTED THAT THE RESERVOIR LIP RING WAS DAMAGED. THE CUSTOMER REPORTED THAT THE RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO INSULIN PUMP. 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 9529203 ↗
• MalfunctionDec 24, 2019Premature Discharge of Battery; Premature Discharge of Battery

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. THE CUSTOMER¿S BLOOD GLUCOSE WAS 178 MG/DL AND 78 MG/DL. THE CUSTOMER STATED THAT THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER WAS ABLE TO COMPLETE REWIND. THE TROUBLESHOOTING WAS PERFORMED AND CUSTOMER ALSO STATED THAT THEY RECEIVED ANOTHER UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. CUSTOMER STATED THAT ALARM OCCURRED SHORTLY AFTER INSERTING A NEW BATTERY. CUSTOMER ALSO STATED THAT THEY HAD NOT EXPERIENCED MULTIPLE UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516616 ↗
• InjuryDec 17, 2019Obstruction of Flow; Obstruction of Flow

  THE CUSTOMER'S DOCTOR REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS IN THE INTENSIVE CARE UNIT ON AN UNKNOWN DATE WITH UNKNOWN BLOOD GLUCOSE LEVEL. THEY MENTIONED THAT THE INSULIN PUMP HAD NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 9484431 ↗
• MalfunctionDec 11, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem; Device Difficult to Program or Calibrate; Obstruction of Flow; Battery Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTON OF INSULIN PUMP WAS STICKY OR NON-RESPONSIVE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARMS AND DIMINISHED BATTERY LIFE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9450045 ↗
• InjuryDec 3, 2019Failure to Cycle; No Apparent Adverse Event; Failure to Cycle; No Apparent Adverse Event

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HOSPITALIZED DUE TO HYPERGLYCEMIA ON (B)(6) 2019. CUSTOMER¿S BLOOD GLUCOSE LEVEL VALUE WHEN ADMITTED TO HOSPITAL 432 MG/DL AND OVER 400 MG/DL. CUSTOMER REPORTED THAT THE HIGH BLOOD GLUCOSE OVER DELIVERY OF INSULIN DIDN'T DISCONNECT WHEN PRIMING. CUSTOMER TREATED WITH MANUAL INJECTION. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS AND INSULIN PUMP ERROR ALARM OCCURRED. CUSTOMER WAS UNABLE TO DESCRIBE ANY POSSIBLE DAMAGE TO THE DRIVE SUPPORT CAP. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9407474 ↗
• MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Patient Device Interaction Problem; Device Difficult to Program or Calibrate; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BUTTON ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. THE CUSTOMER REPORTED THAT THERE WAS BIG CRACK ALONG THE BATTERY COMPARTMENT AND 2 CRACKS ALONG RESERVOIR WINDOW, HAD TO PRESS ACT BUTTON HARDER OR MORE IN A CERTAIN AREA IN ORDER TO RESPOND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9360453 ↗
• MalfunctionNov 19, 2019Display or Visual Feedback Problem; Obstruction of Flow; Display or Visual Feedback Problem; Obstruction of Flow

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD BACK LIGHT NEVER WORKED MAKING HARD TO READ DISPLAY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED INSULIN PUMP HAD MULTIPLE RANDOM NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9339644 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150019, 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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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-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