Paradigm® REAL-Time Revel™ MMT-723RNAL (UDI 00613994904409)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00613994904409), received between Jul 7, 2017 and May 11, 2020 — classified as 8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2020No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CUSTOMER EXPERIENCED HYPERGLYCEMIA. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 487 MG/DL. THE CUSTOMER DID NOT TROUBLESHOOT FOR HIGH BLOOD GLUCOSE DUE TO DAMAGE ON THE INSULIN PUMP. THE CUSTOMER STATED THAT THE BOTTOM OF THE INSULIN PUMP CAME OFF. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 10042398 ↗
• MalfunctionApr 25, 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 UNKNOWN. THE CUSTOMER REPORTED THAT THE BUTTONS WERE STICKY PERIODICALLY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8548586 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP HAD HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 186 MG/DL, CURRENT BLOOD GLUCOSE WAS 600 MG/DL. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8368865 ↗
• MalfunctionFeb 15, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. 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: No Consequences Or Impact To Patient

  MAUDE report 8345383 ↗
• InjuryFeb 5, 2019Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 555 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 389 MG/DL. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 8307224 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 413 MG/DL AT THE TIME OF INCIDENT AND THE CURRENT BLOOD GLUCOSE OF THE CUSTOMER WAS 162 MG/DL. CUSTOMER REPORT OTHER BLOOD GLUCOSE VALUE WAS 400 MG/DL. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT AND LOW BLOOD GLUCOSE EPISODE. CUSTOMER DID NOT PROVIDE ANY SYMPTOMS REGARDING TO HIGH BLOOD GLUCOSE EPISODE. CUSTOMER TREATED WITH INSULIN PUMP FOR HIGH BLOOD GLUCOSE AND CUSTOMER TREATED WITH FOOD FOR LOW BLOOD GLUCOSE. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR HIGH BLOOD GLUCOSE AND LOW BLOOD GLUCOSE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 8234633 ↗
• MalfunctionNov 30, 2018Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Premature Discharge of Battery; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE VALUE WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS ASSISTED WITH TROUBLESHOOTING AND DECLINED FOR UNEXPECTED RESTART. THE INSULIN PUMP WILL NOT RETURN FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8119019 ↗
• MalfunctionApr 4, 2018Device Inoperable; Device Operates Differently Than Expected

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP HAD A KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 200 MG/DL AT THE TIME OF INCIDENT. CUSTOMER STATED THAT THE INSULIN PUMP UP AND DOWN BUTTONS STOPPED WORKING. NO SIGNIFICANT EVENTS LEADING TO KEYPAD ANOMALY WERE OBSERVED. KEYPAD ANOMALY TROUBLESHOOTING WAS PERFORMED AND CONFIRMED THAT TIME IS NOT ADVANCING EVEN AFTER THE BATTERY HAS BEEN 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 7396230 ↗
• InjuryDec 13, 2017Inappropriate or Unexpected Reset

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD UNEXPECTED RESTART. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 67 MG/DL AT THE TIME OF INCIDENT. IT ALSO STATED THAT ALARM OCCURRED AFTER INSERTION OF NEW BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hypoglycemia

  MAUDE report 7115652 ↗
• MalfunctionNov 1, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED UNEXPECTED RESTART, BATTERY ALERT GREATER THAN 1 WEEK, LOW RESERVOIR ALARM, LOW BATTERY ALERT GREATER THAN 1 WEEK AND EXTERNAL RAM CRC ERROR. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THERE IS NO INDICATION OF ISSUE BEING RESOLVED. 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 IS EXPECTED TO BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6995308 ↗
• InjurySep 22, 2017Device Operates Differently Than Expected

  CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2017 WITH BLOOD GLUCOSE OF 34 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 217 M/DL AT THE TIME OF THE CALL. THE CUSTOMER HAS BEEN EXPERIENCING LOWS FOR OVER A WEEK. THE CUSTOMER WAS GIVEN GLUCOSE TABLETS AND DEXTROSE TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS INCOHERENCE. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. TROUBLESHOOTING WAS COMPLETED AND THE CUSTOMER BELIEVES THE PUMP IS OVER DELIVERING INSULIN. THE CUSTOMER WAS AT 541 MG/DL ON THE MORNING OF THE CALL AND TREATED WITH 25 UNITS OF INSULIN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 6887090 ↗
• MalfunctionSep 12, 2017Sticking; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A VIBRATE AND KEYPAD ANOMALY. TROUBLESHOOTING FOR BUTTON ERROR/KEYPAD ANOMALY WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD THREE VIBRATIONS WITH NO REASON. THE UP AND ACT BUTTONS WERE ALSO STICKING, AS WELL AS, THE B BUTTON AT TIMES. THE CUSTOMER ALSO STATED THAT THERE WAS NO SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUES AND THAT THE TIME ON THE CLOCK ADVANCED WHEN MONITORED FOR ONE MINUTE. 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 6860502 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME OF CALL. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH INSULIN PUMP. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6804837 ↗
• MalfunctionAug 10, 2017Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THE INSULIN PUMP ALARMED UNEXPECTED RESTART. THE ALARM WAS NOT RESOLVED DURING TROUBLESHOOTING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6785773 ↗
• MalfunctionJul 17, 2017Device Inoperable

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS DROPPED AND IT STOPPED WORKING. THE CUSTOMER'S BLOOD GLUCOSE READING WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER THEIR DOCTOR'S INSTRUCTION. THE PRODUCT WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6719991 ↗
• InjuryJul 14, 2017High Test Results

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6)2017 AT AFTERNOON WITH BLOOD GLUCOSE OF 660 MG/DL. CUSTOMER CURRENT BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER BLOOD GLUCOSE READING WHILE HOSPITAL ADMISSION WAS 550 MG/DL. EMERGENCY MEDICAL SERVICE WAS DISPATCHED FOR THE CUSTOMER. THE HOSPITAL NAME WAS (B)(6). THE HOSPITAL PHONE NUMBER (B)(6). (B)(6) REPORTED THE INCIDENT. CUSTOMER WAS HAVING HIGH BLOOD GLUCOSE READING OVER MONTH, CUSTOMER TRIED TO REDUCE THEIR NUMBER WITH INSULIN BUT IT DID NOT REDUCE. CUSTOMER WENT TO HOSPITAL BECAUSE OF THE HIGH BLOOD GLUCOSE READING PER HEALTHCARE PROVIDER. CUSTOMER TREATED HIGH BLOOD GLUCOSE READING WITH MANUAL INJECTION. DRIVE SUPPORT CONDITION WAS NOT MENTIONED. CUSTOMER WAS WEARING INSULIN PUMP DURING HOSPITALIZATION. CUSTOMER DID NOT MENTION CANNULA CONDITION. INSULIN PUMP WILL BE RETURNING FOR ANALYSIS.

  Patient problems: Hyperglycemia

  MAUDE report 6714669 ↗
• MalfunctionJul 7, 2017No Display/Image; Device Displays Incorrect Message

  THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED AND HAD A BLANK DISPLAY BEFORE AND AFTER A BATTERY CHANGE. CUSTOMER'S BLOOD GLUCOSE WAS 76MG/DL AT THE TIME OF INCIDENT. THE PRODUCT WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692684 ↗

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-1594-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723
• Z-1591-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
• 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-1590-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-722K
• Z-1592-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-523K
• Z-1593-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-723K
• Z-1589-2020 · Jun 27, 2019 · Open, Classified
  Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
• 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