Paradigm® REAL-Time Revel™ MMT-523LNAL (UDI 00643169479616)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169479616), received between Jun 5, 2017 and Apr 27, 2020 — classified as 6 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP¿S RETAINER RING WAS BROKEN HOWEVER RESERVOIR WAS ABLE TO LOCK IN PLACE. 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 10000066 ↗
• MalfunctionAug 15, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NO LONGER WORKING AFTER COUPLE OF YEARS IN USE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 149 MG/DL. THE CUSTOMER REPORTED THAT THE INSULIN PUMP STARTED ALARMING, ASKING TO REWIND. THEY REPORTED HAT THEY HAD BEEN TRYING TO DO A REWIND, BUT NOTHING WAS HAPPENING, LIKE THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER REPORTED THAT THE TIME ON THE INSULIN PUMP WAS ADVANCING. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8900111 ↗
• MalfunctionAug 1, 2019Mechanical Problem; Patient Device Interaction Problem; Mechanical Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A MOTOR ERROR, CRACK ON CASING BY RESERVOIR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8849421 ↗
• MalfunctionJun 11, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD DAMAGE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. CUSTOMER STATES THE PLASTIC PIECE ON INSULIN PUMP WHERE BATTERY GOES CHIPPED OFF AND ALSO CRACKS ON BATTERY COMPARTMENT AS WELL AS THE SCREEN. CUSTOMER STATES THE RESERVOIR ABLE 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 8686186 ↗
• InjuryMay 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER¿S HUSBAND REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 550 MG/DL TO 560 MG/DL. AT THE TIME OF INCIDENCE. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 323 MG/DL. CUSTOMER DID NOT ALLEGING INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER WERE TREAT WITH INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 8581102 ↗
• MalfunctionMar 18, 2019Obstruction of Flow; Power Problem; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Power Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER STATED INSULIN PUMP HAD NO DELIVERY ALERT AND ALSO REJECT NEW BATTERIES. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8428380 ↗
• InjuryMar 18, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALLEGES UNDER DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE LEVEL WAS 248 MG/DL. CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS TREATED WITH MANUAL INJECTION FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVEL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER REPORTED THAT THEY HAVE CONTACTED THEIR HEALTHCARE PROFESSIONAL REGARDING THE HIGH BLOOD GLUCOSE LEVEL. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, NOR WAS EMERGENCY MEDICAL SERVICE DISPATCHED AS A RESULT OF HIGH BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER IS UNABLE TO UPLOAD TO CARELINK. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8427803 ↗
• MalfunctionDec 28, 2018Failure to Cycle; Failure to Cycle

  IT WAS REPORTED THAT THEIR INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER STATED THAT THEY ARE NOT ABLE TO EXIT THE PREPARING TO PRIME LOOP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL NEED TO BE REPLACED AND 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 8201973 ↗
• MalfunctionOct 19, 2018Connection Problem; Connection Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS DAMAGED. CUSTOMER STATES RESERVOIR WAS FALLING OFF, RESERVOIR CHAMBER WAS WORN DOWN ON THE EDGE, RUBBER BAND ON THE PISTON WAS VISIBLE. CUSTOMER¿S BLOOD GLUCOSE WAS 385 MG/DL AT TIME OF INCIDENT THIS HIGH BLOOD GLUCOSE WAS TREATED WITH INSULIN INJECTION. CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. CUSTOMER ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 7985308 ↗
• MalfunctionOct 4, 2018Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD MOTOR ERROR. CUSTOMER BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER ALSO STATED THAT THE INSULIN PUMP NOT ALARMING WHEN BATTERY WAS LOW AND SLOWER REWIND. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7935455 ↗
• MalfunctionApr 13, 2018Crack

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE PLASTIC RIM ON THE RESERVOIR CHAMBER WAS CRACKED OFF. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7428123 ↗
• MalfunctionMar 16, 2018No Display/Image; Loose or Intermittent Connection

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR WAS UNABLE TO LOCK IN PLACE WHEN INSERTED INTO PUMP AND PUMP HAD PARTIAL DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. 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 7346072 ↗
• MalfunctionJan 24, 2018Break; No Display/Image

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED AND THE DISPLAY WAS PARTIAL. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 152MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THEY JUST PUSHED THE BUTTON AND ONLY HALF THE SCREEN WAS SHOWING AND THE OTHER HALF WAS MISSING. CUSTOMER STATED IT JUST STARTED THIS MORNING, WHEN THEY PUSHED THE BUTTON AND THEN THE LEFT ONE THIRD CORNER WAS NOT SHOWING ANY PRINTING. THEY TRIED TO CHANGE THE BATTERY AND SAME RESULTS. 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 7215556 ↗
• MalfunctionDec 11, 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 104 MG/DL AT THE TIME OF THE INCIDENT. CUSTOMER STATED THAT CUSTOMER STATED THAT SHE GOT A COMPROMISED FORCE SENSOR SYSTEM LAST NIGHT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS FLUSH. CUSTOMER STATED THAT SHE TOOK BATTERY OUT OF INSULIN PUMP AND PUT BACK IN AND NOW HAS A BATTERY OUT LIMIT. CUSTOMER DECLINES TO TROUBLESHOOT FOR BATTERY OUT LIMIT, 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: No Consequences Or Impact To Patient

  MAUDE report 7105108 ↗
• InjuryOct 26, 2017Device Displays Incorrect Message

  THE CUSTOMER¿S SPOUSE REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 400 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER¿S SPOUSE STATED THAT THE INSULIN PUMP . THE CUSTOMER¿S PARENT STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL AND THAT THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS AND WAS ABLE TO COMPLETE THE REWIND PROCESS. CUSTOMER HAD EXPERIENCED A HIGH BLOOD GLUCOSE OF 400 MG/DL AND TREATED WITH MANUAL INJECTION. NO HIGH BLOOD GLUCOSE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER¿S SPOUSE WAS ADVISED TO HAVE CUSTOMER 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 6981640 ↗
• MalfunctionOct 24, 2017Device Displays Incorrect Message

  THE CUSTOMER WAS REPORTED VIA PHONE CALL THAT, THE CUSTOMER RECEIVED WITH UNEXPECTED RESTART ALARM AFTER BATTERY CHANGE. THE BLOOD GLUCOSE WAS 80 MG/DL AT THE TIME OF THE INCIDENT. TROUBLESHOOTING STEPS WERE GUIDED FOR UNEXPECTED RESTART ALARM. CUSTOMER ALSO REPORTED LOW BATTERY ALARM. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6971349 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVEL. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 481 MG/DL AT THE TIME OF INCIDENT AND CURRENT BLOOD GLUCOSE LEVEL WAS 168 MG/DL. THE CUSTOMER WAS NEITHER HOSPITALIZED NOR IN EMERGENCY ROOM FOR HIGH BLOOD GLUCOSE LEVEL. IT ALSO STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER DECLINED TROUBLESHOOT FOR HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6917936 ↗
• MalfunctionSep 25, 2017Break

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THAT THE PLASTIC AT THE TOP OF THE RESERVOIR BROKE AND IS UNABLE PUT THE RESERVOIR IN THERE ANYMORE. THE CUSTOMER DID NOT TROUBLESHOOT THE ISSUE. 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 6891832 ↗
• MalfunctionAug 21, 2017Display or Visual Feedback Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP WOULD NOT EXIT THE PREPARING TO PRIME SCREEN. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 110MG/D AT THE TIME OF THE INCIDENT. CUSTOMER STATED THEY WERE NOT WEARING THE INSULIN PUMP DURING PRIMING. THE CUSTOMER WAS ADVISED TO HOLD DOWN THE ACT BUTTON UNTIL RECEIVING A SECOND SERIES OF BEEPS AND NOR NUMBERS APPEAR ON THE DISPLAY. THE CUSTOMER STATED THAT THEY DID NOT RECEIVE THE BEEPS NOR DID THE NUMBERS APPEAR ON THE SCREEN. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP A REPLACEMENT WOULD BE SENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6809085 ↗
• MalfunctionJul 31, 2017No Display/Image; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 138 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED THE INSULIN PUMP NOT WORKING. THE CUSTOMER THOUGHT THE BATTERIES WERE DEAD, CHANGED OUT THE BATTERIES AND NOTHING IS COMING, THE SCREEN IS BLANK. THE CUSTOMER DID TROUBLESHOOT THE ISSUE. 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 6755605 ↗
• InjuryJun 12, 2017Device Displays Incorrect Message

  THE CUSTOMER'S CLINICAL SPECIALIST REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED MOTOR ERROR AND A NO DELIVERY ALARM. THE CALLER STATED THE CUSTOMER JUST CAME FROM THE EMERGENCY ROOM AND WAS CURRENTLY AT THE DOCTOR'S OFFICE. THE CALLER REPORTED THE CUSTOMER HAD HIGH BLOOD GLUCOSE AND DID NOT KNOW HOW TO TREAT. THE NURSE DID NOT PROVIDE THEIR BLOOD GLUCOSE VALUE AT THE TIME OF THE INCIDENT. DURING TROUBLE SHOOTING A MOTOR ERROR AND RECURRING NO DELIVERY ALARMS WERE FOUND. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6633728 ↗
• InjuryJun 5, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL OF LOW BLOOD GLUCOSE OF 40MG/DL.  CUSTOMER TREATED WITH JUICE.  CUSTOMER DECLINED TO TROUBLESHOOT AND INDICATED THAT THEY HAD NOT EATEN FOOD THAT DAY WHICH LED TO THEIR HIGH READING.  NO FURTHER DETAILS GIVEN.

  Patient problems: Hypoglycemia

  MAUDE report 6612933 ↗

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-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-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-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-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-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