Paradigm® REAL-Time Revel™ MMT-523NAP (UDI 00613994743879)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994743879), received between Jun 12, 2017 and May 19, 2020 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED VIA PHONE CALL BY THE CUSTOMER'S PARENT THAT THE CUSTOMER RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2020 WITH BLOOD GLUCOSE OF OVER 700 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN INTRAVENOUS INSULIN TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS VOMITING AND FREQUENT URINATION. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CALLER DECLINED. THE CALLER STATED THE CUSTOMER WAS GETTING NO DELIVERY ALARMS. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10069223 ↗
• MalfunctionApr 8, 2020Obstruction of Flow; Battery Problem; Power Problem; Priming Problem; Obstruction of Flow; Battery Problem; Power Problem; Priming Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP WAS SQUIRT INSULIN OUT DURING PRIMING,INSULIN PUMP REJECTED NEW BATTERIES. CUSTOMER ALSO REPORTED THAT INSULIN PUMP RECEIVED NO DELIVERY ALARM AND WHEN BATTERY WAS LOW IT DID NOT ALERT. 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 9940597 ↗
• MalfunctionJun 12, 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. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120 MG/DL. THE CUSTOMER STATED THAT THEY PUTTING IN THE AMOUNT OF INSULIN IT KEPT SCROLLING DOWN WITHOUT INPUT. THE CUSTOMER WAS PERFORMED SELF AND DISPLACEMENT TEST AND IT WAS PASSED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8690086 ↗
• MalfunctionMar 15, 2019Computer Software Problem; Application Program Version or Upgrade Problem; Computer Software Problem; Application Program Version or Upgrade Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NEW SOFTWARE RELEASE DETECTED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTS THEY WERE ABLE TO CLEAR THE ALARM. CUSTOMER STATES THEY RECEIVE ANOTHER INSULIN PUMP ERROR. CUSTOMER STATES INSULIN PUMP HAD SECOND OCCURRENCE OF ERROR. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8424159 ↗
• MalfunctionFeb 12, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR POSITION ENCODER ERROR. THE CUSTOMER¿S BLOOD GLUCOSE WAS 287 MG/DL AT THE TIME OF INCIDENT. CUSTOMER REPORTS 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 8330476 ↗
• MalfunctionOct 18, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER'S PARENT REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD AUDIO ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER'S PARENT ALSO REPORTED THAT THE INSULIN PUMP HAD A RAINBOW DISPLAY AND IT'S HARD TO SEE THE SCREEN. THE CUSTOMER'S PARENT REPORTED THAT THE REWIND MOTOR WAS LOUD. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7981404 ↗
• MalfunctionSep 19, 2018Power Problem; Power Problem

  CUSTOMER REPORTED VIA PHONE CALL PRIME ANOMALY ON THE INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ADVISED INSULIN SQUIRTED OUT OF THE TUBING DURING MANUAL PRIME. 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 7891995 ↗
• InjuryJan 5, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED MULTIPLE PUMP ERROR ALARMS. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 73 MG/DL THIS MORNING AND AT 10:55AM IT WAS 238 MG/DL. THE CUSTOMER STATED THAT THE THEY DID RECEIVED FAILED BATTERY TEST ALARM. THE CUSTOMER WENT INTO THE EMERGENCY ROOM TO GET HELP WITH THE INSULIN PUMP AS SHE COULD NOT CLEAR THE ALARM. THE INSULIN PUMP WAS NOT ALARMING BATTERY OUT LIMIT AT TIME OF CALL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7169359 ↗
• InjuryNov 10, 2017Device Displays Incorrect Message; Improper Flow or Infusion

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER STATES KEEP RUNNING HIGH BLOOD GLUCOSE LEVEL WAS 390 AND 357 MG/DL AND TREATED WITH SYRINGE. THE CUSTOMER ALSO REPORTED THAT THE INSULIN WAS SQUIRTING DURING MANUAL PRIME PROCESS. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. 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: Hyperglycemia

  MAUDE report 7022236 ↗
• MalfunctionOct 24, 2017Device 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 170 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THEY ARE RECEIVING A COMPROMISED FORCE SENSOR SYSTEM ALARM. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. 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 6972518 ↗
• MalfunctionSep 15, 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 NO SIGNIFICANT EVENT LEADING TO BUTTON ERROR. BUTTON ERROR TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS NOT ADVANCING EVEN AFTER THE BATTERY HAS BEN CHANGED. 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 6870821 ↗
• MalfunctionSep 14, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM AND INSULIN SQUIRTED OUT OF THE TUBING DURING MANUAL PRIME. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS UNKNOWN. THE CUSTOMER WAS DISCONNECTED DURING PRIME. THE DRIVE SUPPORT CAP WAS NOT DAMAGED. IT WAS ADVISED A REPLACEMENT WILL BE SENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6866777 ↗
• InjuryAug 15, 2017Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY AT HOME. THE CUSTOMER WAS HOSPITALIZED BEFORE PASSING AWAY DUE TO A BROKEN HIP. THE CAUSE OF DEATH WAS RENAL FAILURE. THE CALLER STATED THAT THE CUSTOMER HAD A BROKEN HIP THAT MAY HAVE LED TO THE CUSTOMER'S PASSING. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF DEATH. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF DEATH. THE PUMP HAD BEEN DISCONNECTED GREATER THAN 48 HOURS PRIOR TO PASSING. THE CUSTOMER WAS DISCONNECTED AS THEY WERE OVERDOSED OR GIVEN TOO MUCH INSULIN WITH INSULIN TWICE WHILE IN THE HOSPITAL FOR THE BROKEN HIP. THE CUSTOMER WAS NOT USING SENSORS. THE CALLER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS.

  Patient problems: Death

  MAUDE report 6796179 ↗
• MalfunctionJun 12, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. CUSTOMER DID NOT RECALL BLOOD GLUCOSE AT THE TIME OF INCIDENT. TROUBLESHOOT WAS PERFORMED. CUSTOMER SAID THE PUMP WILL SQUIRT OUT INSULIN THAN NUMBER OF THE INSULIN WOULD NOT GO UP BUT INSULIN WOULD STILL SQUIRT OUT AND ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE ALARM OCCURRED DURING REWIND AND PRIME SEQUENCE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACKUP PLAN PER HEALTHCARE PROVIDER INSTRUCTION. THE INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633245 ↗

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-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-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-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• 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