Paradigm® REAL-Time Revel™ MMT-723LNAL (UDI 00613994904508)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994904508), received between Jun 6, 2017 and Aug 16, 2019 — classified as 5 injuries, 9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2019Display or Visual Feedback Problem; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem; Display or Visual Feedback Problem; Material Integrity Problem; Patient Device Interaction Problem; Priming Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER STATED THAT IN JANUARY THEIR BLOOD GLUCOSE LEVEL WAS OVER 500 AND WOKE UP WITH 578 MG/DL THEN WENT TO HOSPITAL. CUSTOMER REPORTED THAT THE INFUSION SET HEAD WAS BROKEN BUT INSULIN PUMP DID NOT GAVE HIM NO DELIVERY ALARM. CUSTOMER ALSO STATED THAT THE INSULIN PUMP REJECTED NEW BATTERIES. CUSTOMER STATED THAT THE INSULIN WAS SQUIRTED OUT DURING PRIMING. CUSTOMER WAS ON INTRAVENOUS INSULIN AT THE HOSPITAL. CUSTOMER STATED THAT THE INSULIN PUMP WAS WORKING AS IT SHOULD. CUSTOMER GOT HOME FROM WORK AT 11 PM AND HAD 10 CARBOHYDRATES AND GAVE BOLUS WITH A BLOOD GLUCOSE AT 93 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT FOR ANY ISSUES AT THIS MOMENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8900599 ↗
• MalfunctionAug 14, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP ESC AND ACT BUTTONS WERE NOT RESPONDING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. 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 8892122 ↗
• MalfunctionAug 12, 2019Failure to Cycle; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Patient Device Interaction Problem; Failure to Cycle; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS WERE UNRESPONSIVE. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. THERE WAS RAINBOW EFFECT ON SCREEN, INSULIN SQUIRTS WHEN PRIMING, BUTTONS UNRESPONSIVE, E ALARMS, BACKLIGHT NOT AS BRIGHT AS BEFORE, SCRATCHES ON THE SCREEN MAKE SCREEN HARD TO READ. THE TROUBLESHOOTING WAS NOT MENTIONED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8882548 ↗
• MalfunctionDec 20, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOTOR ERROR. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. THE CUSTOMER REPORTED THAT THEY WERE REWINDING THE INSULIN PUMP AND WAS CHANGING THE SET AND MOTOR ERROR ALARM OCCURRED. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A MOTOR POSITION ENCODER ERROR. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8183460 ↗
• MalfunctionDec 3, 2018No Display/Image; Insufficient Device Problem Information; No Display/Image; Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 73 MG/DL. THE CUSTOMER REPORTED THAT THE LIGHT OF THE INSULIN PUMP WORKED. THE CUSTOMER ALSO REPORTED THAT THE SCREEN WAS REFLECTING HALVES ON THE OPPOSITE SIDES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE CUSTOMER WAS ADVISED THE INSULIN PUMP WILL BE REPLACED AS PER TROUBLESHOOT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8123576 ↗
• InjuryNov 20, 2018Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD EXPERIENCED HIGH BLOOD GLUCOSE AND INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 500 MG/DL. THE CUSTOMER REPORTED THAT THEY RECEIVED A MOTOR ERROR ALARM AND NO DELIVERY ALARM. CUSTOMER WAS ABLE TO SUCCESSFULLY CLEAR THE ALARM. CUSTOMER WAS UNABLE TO COMPLETE PUMP REWIND. THE CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE. THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND WAS ADVISED TO REFER TO BACK UP PLAN, PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8088695 ↗
• MalfunctionNov 16, 2018Premature Discharge of Battery; Appropriate Device Problem Term/Code Not Available; Premature Discharge of Battery; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERRORS. THE CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE CUSTOMER WAS ABLE TO CLEAR THE ALARM. THE CUSTOMER STATED THAT THE ALARM WAS DID NOT OCCUR SHORTLY AFTER INSERTING A NEW BATTERY AND RECURRING DURING NORMAL PUMP USE. CUSTOMER STATED THE PUMP WORKED FOR A LITTLE WHILE AND THEN COMPLETELY SHUT OFF. CUSTOMER ADVISED THE PUMP WILL NEED TO BE REPLACED. ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. COMPLAINTS TEXT (B)(6) 2018, (B)(4) INITIAL NOTES: CUSTOMER CALLED BACK STATED HE HEARD THE RETURN POLICY MESSAGE AND CALL DISCONNECTED WANTED TO COMPLETE AND VERIFY SHIPPING ADDRESS INQUIRED WHAT LED UP TO THE COMPLAINT. CUSTOMER RESPONSE: REPLACEMENT PUMP CUSTOMER'S OUTCOME PERTAINING TO THE COMPLAINT: VERIFIED CUSTOMER SHIPPING ADDRESS AND RELEASE RMA FOR PUMP REPLACEMENT PER PERVIOUS NOTES ON ACCOUNT SHIP: NOTHING/RETURN: NOTHING. COMPLAINTS TEXT (B)(6) 2018, ERP_RFC_USER RELATED TO SVN (B)(4). COMPLAINTS TEXT (B)(6) 2018, (B)(4) INITIAL NOTES: CUSTOMER STATED THAT HE GOT AN A21

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077117 ↗
• MalfunctionMay 28, 2018Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT NEW SOFTWARE RELEASE DETECTED AND FAILURE OF FLASH MEMORY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT TIME OF INCIDENT. CUSTOMER WAS NOT ABLE TO PERFORM SELF TEST DUE INSULIN PUMP GET OFF. ERROR TABLE INDICATES THE PUMP SHOULD BE REPLACED. THE INSULIN PUMP WILL BE RETURNED BE FOR THE ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7547360 ↗
• MalfunctionMar 14, 2018Loose or Intermittent Connection; Device 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 115 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSE. 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 7339925 ↗
• InjuryDec 27, 2017Crack

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND LOW BLOOD GLUCOSE AND CRACK ON THE BATTERY COMPARTMENT ON INSULIN PUMP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OF 46-400 MG/DL. CUSTOMER TREAT LOWS WITH FOOD AND HIGHS WITH MANUAL INJECTIONS. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH AND LOW READINGS. CUSTOMER PERFORMED TROUBLESHOOT AND CUSTOMER REPORTS DAMAGE TO PUMP. THE CUSTOMER STATED BATTERY COMPARTMENT LIP IS CHIPPING. 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: Hyperglycemia

  MAUDE report 7147930 ↗
• MalfunctionOct 16, 2017Device Alarm System

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM DURING REWINDING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER REPORTED HE WAS CHANGING HIS SET THIS MORNING AND HIS PUMP GAVE COMPROMISED FORCE SENSOR SYSTEM ALARM. THE DRIVE SUPPORT CAP APPEARED NORMAL (RECESSED). THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6951370 ↗
• MalfunctionSep 12, 2017Device Displays Incorrect Message; Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED UNEXPECTED RESTART. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER REPORTED A SERIOUS DYSFUNCTION WITH THE INSULIN PUMP. THE CUSTOMER STATES IT IS LOCKED ON A SCREEN AND GIVING A WARNING BEEP. THE CUSTOMER DID TROUBLESHOOT THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6860447 ↗
• InjuryJul 18, 2017Device Operates Differently Than Expected

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL OF 446 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE READING. CUSTOMER ALSO REPORTED FAILED BATTERY TEST BUT THE ISSUE WAS RESOLVED. INSULIN PUMP WILL NOT BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6721747 ↗
• InjuryJun 6, 2017Device Displays Incorrect Message

  CUSTOMER REPORTED VIA PHONE CALL, THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 412 MG/DL AND DIABETIC KETOACIDOSIS ON (B)(6)2017.  CUSTOMER WAS AT HOME TREATING ON A SLIDING SCALE FOR HIGH BLOOD GLUCOSE AND SHE WENT INTO DIABETIC KETOACIDOSIS AT 3 AM. SHE WOKE UP AND CALLED THE AMBULANCE AS SHE THOUGHT WAS ILL. HER BLOOD GLUCOSE WAS 179 MG/DL AND THEN BY 12 THE AMBULANCE GOT THERE AND GOT HER OUT OF DIABETIC KETOACIDOSIS. TWO HOURS LATER HER BLOOD GLUCOSE WAS UP AT 411 MG/DL AND SHE WENT INTO DIABETIC KETOACIDOSIS AND WAS ADMITTED.  CUSTOMER WAS EXPERIENCING SYMPTOMS SUCH AS VOMITING AND FEELING ILL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. TROUBLESHOOTING WAS PERFORMED ON THE INSULIN PUMP. THE DRIVE SUPPORT CAP WAS REPORTED AS NORMAL. CUSTOMER WASN'T WEARING THE PUMP AT THE TIME SO CUSTOMER WAS UNABLE TO CHECK FOR LEAKS OR AIR BUBBLES. CUSTOMER DECLINED TO CHECK FOR SITE AND INSULIN ISSUES. CUSTOMER STATED THE INSULIN PUMP ALWAYS ALARM NO DELIVERY AND THAT NIGHT THE CANNULA WAS NOT BENT. CUSTOMER DID CHECK HER SETTINGS AND NO ANOMALIES WERE NOTED. CUSTOMER D

  Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia

  MAUDE report 6615624 ↗

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-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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1587-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
• Z-1588-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• 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